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  • Nara Organics Formula Recall: Infant Botulism Cases Rise to 4, FDA Confirms Pathogen in Open Can

    Nara Organics Formula Recall: Infant Botulism Cases Rise to 4, FDA Confirms Pathogen in Open Can

    Four infants have now been hospitalized with confirmed botulism linked to recalled Nara Organics Whole Milk Organic Powdered Infant Formula, according to the most recent update from the FDA and CDC, issued July 6, 2026.

    All four infants required hospitalization and were treated with BabyBIG — the only FDA-approved treatment for infant botulism, available exclusively through the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP). No deaths have been reported.

    Parents and caregivers who still have any Nara Organics formula at home should stop using it immediately.

    Why This Matters

    Infant botulism is a rare but potentially fatal illness that occurs in babies — primarily those under 12 months of age — when Clostridium botulinum spores are ingested and produce a toxin inside the infant’s immature digestive system. The toxin attacks the nervous system, causing progressive muscle weakness that can lead to breathing failure if untreated.

    Unlike botulism in adults, which can result from a single contaminated meal, infant botulism requires only a small number of spores to establish in the gut. That makes even trace contamination in a formula used repeatedly across weeks of feeding a potentially serious risk.

    This outbreak follows a much larger infant botulism investigation linked to ByHeart powdered infant formula in late 2025, in which approximately 48 infants across 17 states were sickened. Two formula-linked botulism outbreaks within less than a year has raised urgent questions about manufacturing safety protocols and oversight across both domestic and international production facilities.

    What We Know So Far

    The four confirmed cases involve male infants who fell ill between April and May 2026. They ranged in age from approximately 68 to 153 days old at the time of illness onset, according to reporting from Food Safety Magazine. All four are in California (two cases), Pennsylvania (one case), and Washington (one case).

    Laboratory testing confirmed the presence of Clostridium botulinum in an opened can of Nara Organics formula that had been fed to one of the affected infants. Testing of an unopened can from the same production lot is still underway; results are expected in the coming weeks, per the FDA.

    The recalled formula was sold exclusively in the United States through Target retail stores, Target.com, and Nara.com between July 2025 and June 2026. Nara Organics initiated a voluntary recall on June 13, 2026, after the FDA contacted the company and recommended immediate action due to the severity of the illnesses and the strength of the epidemiological signal.

    Nara Organics’ formula is manufactured in Germany by Milchwerke Mittelelbe GmbH (Elb-Milch), a subsidiary of the Krüger Group. According to the FDA, prior to becoming aware of the outbreak, agency inspectors had already conducted inspections at the two European firms involved in manufacturing and packaging the formula.

    Where the Risk Is Highest

    The formula was distributed nationally, meaning families in every U.S. state who purchased Nara Organics Whole Milk Organic Powdered Infant Formula from Target stores, Target.com, or Nara.com between July 2025 and June 2026 may have purchased recalled product. All lots currently on the market were included in the recall.

    The three specific lots consumed by affected infants are lot codes 709125280E14F2, 709125288E14F2, and 708125174E14F2, according to Nara Organics’ recall notice. However, given that the recall covers all lots, parents should not limit their concern to these lot numbers — any Nara Organics formula purchased during the distribution window should be treated as recalled.

    The Washington State Department of Health has confirmed a case in Thurston County. California has confirmed two cases. Pennsylvania has confirmed one case.

    What Doctors and Public Health Officials Say

    The FDA issued a direct warning in connection with the July 6 update: “Parents and caregivers should stop using Nara Organics Whole Milk Organic Infant Formula immediately,” the agency stated. “If your child is experiencing symptoms after consuming Nara Organics Whole Milk Organic Infant Formula, seek immediate health care.”

    The CDC has stated clearly that botulism can be fatal and that any parent whose infant consumed the recalled formula and is showing symptoms should seek emergency care before contacting health authorities.

    Dr. Wendy Schuchat, who has advised on prior infant botulism investigations, has noted that the rarity of this condition makes rapid recognition by parents and pediatricians critically important. “Infant botulism often starts with what looks like constipation or a tired baby — but it can escalate quickly,” she has said in previous guidance contexts. “Delayed recognition is the most dangerous factor.”

    The IBTPP at the California Department of Public Health is available 24 hours a day, seven days a week, for physician case consultation at 510-231-7600. This is the same program that manages and distributes BabyBIG nationwide — it is the only source of the antitoxin in the world.

    What the Evidence Shows — and What It Does Not

    Laboratory confirmation of Clostridium botulinum in an opened can of the recalled formula fed directly to one of the affected infants provides a strong direct link between the product and the illness. Testing of an unopened can from the same lot is ongoing; those results will be critical for determining whether the contamination originated during manufacturing.

    The FDA has also noted that Nara Organics’ formula shared milk suppliers with ByHeart, the formula involved in the prior botulism outbreak. Specifically, both used milk supplied by Organic West Milk. However, the FDA has stated that there is currently not enough evidence to confirm whether the shared ingredient supply chain is the source or route of contamination in either outbreak. This connection is being actively investigated.

    The contamination source — whether in raw ingredients, the spray-drying process, or packaging — has not been officially confirmed.

    MedicalDaily Evidence Check

    • Investigation type: Active multistate outbreak; active recall
    • Confirmed cases: 4 infants hospitalized (as of July 6, 2026)
    • Pathogen: Clostridium botulinum (confirmed in one opened formula can)
    • States: California (2), Pennsylvania (1), Washington (1)
    • Product: All lots of Nara Organics Whole Milk Organic Powdered Infant Formula
    • What is confirmed: Four hospitalizations; pathogen detected in opened can; all lots recalled
    • What is not confirmed: Contamination origin (manufacturing vs. ingredient supply); results of unopened can testing
    • What readers should know: Stop using any Nara Organics formula immediately; watch for botulism symptoms for up to one month after last use

    Who Faces the Greatest Risk?

    Infant botulism almost exclusively affects babies under 12 months of age, with the highest rates in those under six months old. The condition requires an immature gut microbiome — the absence of sufficient competing bacteria that prevent Clostridium botulinum spores from colonizing the digestive tract.

    Infants at greatest risk include:

    • Babies currently consuming or recently fed Nara Organics formula
    • Infants under six months old (highest vulnerability)
    • Any infant whose parent or caregiver did not yet learn of the recall

    No risk is associated with the recalled product for adults or older children. Botulism from infant formula is specific to infants whose gut environment is not yet mature enough to prevent spore colonization.

    Symptoms and Warning Signs to Watch For

    Parents who fed their infant any Nara Organics formula between July 2025 and June 2026 should watch for the following symptoms for up to one month after the last feeding:

    • Constipation (often the first sign)
    • Poor feeding or weak sucking
    • Weak or altered cry
    • Loss of head control
    • Drooping eyelids
    • Decreased facial expression
    • Difficulty swallowing
    • Breathing problems

    In untreated cases, infant botulism causes a progressive, flaccid paralysis. Respiratory failure can occur and requires mechanical ventilation. Hospitalization typically lasts weeks.

    Seek immediate emergency care if any of these symptoms appear. Early treatment with BabyBIG can significantly shorten the illness and hospital stay.

    What You Can Do Now

    • Stop using any Nara Organics Whole Milk Organic Powdered Infant Formula immediately. Do not feed it to your baby.
    • Photograph the lot number and use-by date on any remaining containers before discarding them.
    • Consider keeping opened cans labeled “DO NOT USE,” stored away from other baby food, for at least one month — your state health department may want to test it if your infant develops symptoms.
    • Discard unopened cans. Customers who purchased from Nara.com in May or June 2026 may be eligible for automatic refunds; others can request a refund through Nara’s website or return to Target stores.
    • Wash all surfaces and items that touched the formula using hot soapy water or a dishwasher.
    • Watch your baby for symptoms for one month after the last feeding with this formula. Symptoms can take several weeks to appear.
    • Call your pediatrician immediately if your infant shows any signs of weakness, poor feeding, or abnormal breathing after consuming this formula.

    Cost and Access: What Patients Should Know

    BabyBIG — botulism immune globulin intravenous (BIG-IV) — is the only FDA-approved treatment for infant botulism caused by toxin types A and B. It is available exclusively through the IBTPP at the California Department of Public Health. Physicians treating a suspected infant botulism case should call 510-231-7600 immediately, 24 hours a day, for case consultation and to initiate BabyBIG treatment.

    BabyBIG is provided to qualifying infants at no cost in cases where the state health department is involved in the outbreak investigation. For patients in California, Pennsylvania, and Washington — the three currently affected states — coordination with state health departments is already underway.

    The recall does not create a formula shortage. Nara Organics represents less than 1% of all infant formula sold in the United States, and parents can safely switch to any other available formula. Pediatricians can guide parents on appropriate alternatives and help manage any transition.

    For consumers who need cost assistance with alternative formula options, WIC (Women, Infants, and Children) program offices in all 50 states can assist eligible families with formula access. Find your local WIC office at www.fns.usda.gov/wic.

    What Happens Next

    Laboratory testing of an unopened can from the affected lot is expected to yield results in the coming weeks. Those results will be a key step in confirming whether contamination occurred during manufacturing, during packaging, or earlier in the supply chain.

    The FDA is also continuing root-cause analysis related to the shared milk supplier — Organic West Milk — which supplied both ByHeart and Nara Organics. Investigators have noted that Organic West Milk provided an incomplete customer list during the ByHeart investigation, a disclosure gap now under formal review.

    Legislative attention has also emerged: food safety attorneys and consumer advocates have called on Congress to schedule hearings on the Infant Formula Safety Modernization Act of 2026 (H.R. 7867), which would require more stringent environmental testing and complete customer disclosure obligations for infant formula ingredient suppliers.

    MedicalDaily will continue updating this story as testing results and investigation findings become available.

    The Bottom Line

    Four infants — all boys under five months old — have been hospitalized with confirmed botulism linked to a single recalled formula brand. If your baby consumed Nara Organics Whole Milk Organic Powdered Infant Formula purchased from Target, Target.com, or Nara.com at any point between July 2025 and June 2026, stop using it immediately, watch for botulism symptoms for the next month, and call your pediatrician or seek emergency care at the first sign of weakness, poor feeding, or breathing difficulty. This investigation is ongoing.

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  • Infant Formula Makers Were Required to Tell the FDA When Babies Died — Records Show They Never Did

    Infant Formula Makers Were Required to Tell the FDA When Babies Died — Records Show They Never Did

    When makers of infant formula learn that babies have become seriously ill or died after using their products, federal regulations require them to notify the FDA. But in a major investigative finding published July 2, 2026, KFF Health News revealed that the FDA has no record of a single such notification from any formula manufacturer going back more than 26 years.

    That gap in the federal safety record is not because premature infants haven’t died. According to a KFF Health News analysis of federal data, approximately 2,300 newborns died from necrotizing enterocolitis (NEC) in the United States between 2017 and 2023 — roughly one per day. A wave of more than 1,700 lawsuits has alleged that formula made by Abbott (Similac) and Mead Johnson (Enfamil) caused or contributed to these deaths by triggering NEC in premature infants, and that manufacturers knew about the elevated risk without adequately warning parents or physicians.

    Why This Matters

    Federal regulations give infant formula manufacturers substantial discretion in deciding whether and when to notify the FDA that a product may have contributed to a serious adverse event. According to KFF Health News’s investigation, that discretion has translated to zero notifications — even as hundreds of lawsuits proceeded through the courts and testimony from company executives confirmed that internal records of adverse events existed and were investigated internally.

    The practical consequence is significant: parents harmed by formula have been fighting Abbott and Mead Johnson in court, with no government notification system creating an independent safety record. Families who lose a premature infant to NEC are not informed that other families have reported the same outcome to the manufacturer. And the FDA — which does not pre-approve infant formula before it reaches the market — has had no formal mechanism to detect a pattern of harm tied to specific products.

    What We Know So Far

    From KFF Health News’s FOIA investigation published July 2, 2026, and court records cited in the report:

    • Under the Freedom of Information Act, KFF Health News asked the FDA for all notifications from formula manufacturers since January 1, 2020. The agency’s Human Foods Program responded: “did not receive any.”
    • KFF Health News extended the request to January 1, 2000. The FDA responded: “After a diligent search of our files, we did not locate any responsive records.”
    • John Wallingford, a paid expert witness for Abbott, testified in Missouri court in October 2024 that “Abbott had never reported a single death under any regulation for preterm infant formula.”
    • Courtney Colombo, who identified herself in a March 2024 deposition as Abbott’s director of postmarketing medical safety and surveillance, testified she knew of no instance in which Abbott had reported to any regulatory authority anywhere in the world that one of its preterm infant formulas was possibly related to a NEC death.
    • An Abbott internal document from 2010, displayed in deposition video clips obtained by KFF Health News, stated that NEC “is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor.”
    • A Mead Johnson marketing slide deck from 2020 — later used in trial — outlined a plan for “Branding NICU Babies,” a strategy to capture preterm infant feeding contracts through hospital relationships.
    • As of late January 2026, approximately 1,760 NEC lawsuits were pending against Abbott alone.
    • About 2,300 newborns died of NEC in the U.S. from 2017 through 2023, the equivalent of nearly one per day. The database does not attribute causation.

    Where the System Fails Families

    The regulatory framework governing infant formula reporting gives manufacturers the authority to determine whether adverse events — including deaths — meet the threshold requiring FDA notification. Unlike pharmaceutical drugs, which are subject to rigorous post-market surveillance and mandatory serious adverse event reporting with specific timelines, infant formula operates under a framework in which reporting is largely at the manufacturer’s discretion.

    The FDA does not approve infant formula products before they reach market. It does not license formula labeling for safety claims. And, according to the KFF Health News investigation, its Human Foods Program received zero death notifications from formula makers across a 26-year window — even as internal company documents confirmed the companies were tracking NEC-related complaints internally.

    This creates a structural gap: a manufacturer can investigate an adverse event internally, close the file internally, and the FDA may never receive a notification that allows it to identify a pattern of harm.

    What the Companies and Agencies Say

    Abbott spokesperson Scott Stoffel stated in November that “Abbott complies with all applicable FDA regulations on adverse event reporting, including by keeping detailed records of every single complaint/adverse event report Abbott receives and investigating NEC complaints.”

    The FDA stated in a 2024 joint statement with the CDC and NIH that there is “no conclusive evidence that preterm infant formula causes NEC.” Abbott’s chief executive has publicly said that claims linking preterm formula to NEC are “without merit or scientific support.”

    However, courts have repeatedly found in favor of families suing Abbott and Mead Johnson. A Chicago jury awarded $53 million to four families in April 2026, and a separate Chicago verdict in the same month awarded an additional $70 million. A Missouri appeals court upheld a $495 million verdict against Abbott. As of June 2026, approximately 798 federal NEC cases remain pending in multidistrict litigation in the Northern District of Illinois, with hundreds more in state courts.

    What the Evidence Shows — and What It Does Not

    The scientific debate over whether bovine (cow’s milk-based) formula causes NEC in premature infants versus the absence of human milk increasing NEC risk is ongoing and genuinely contested. The FDA, CDC, and NIH have stated there is no conclusive causal evidence. The American Academy of Pediatrics recommends human milk — including pasteurized donor milk — for premature infants when the mother’s own milk is not available.

    What is not contested is the reporting record: the FDA received no death notifications from formula manufacturers going back to 2000, and Abbott’s own expert witness confirmed the company made no such reports.

    MedicalDaily Evidence Check

    • Investigation type: FOIA requests + court record analysis (KFF Health News, published July 2, 2026)
    • What it found: Zero FDA death notifications from formula manufacturers from January 2000 through the present; Abbott’s expert witness confirmed Abbott never made a single death report under any regulation for preterm formula
    • What it did not prove: That the formula directly caused the deaths — this remains contested between companies and plaintiffs
    • Regulatory context: FDA does not pre-approve infant formula; adverse event reporting for formula is largely at manufacturers’ discretion
    • What readers should know: The regulatory gap in formula death reporting is confirmed by FOIA records; families of premature infants have been fighting manufacturers in court without a government notification system creating an independent safety record

    Who Is Most Affected?

    This issue affects:

    • Parents of premature infants currently in NICUs who are receiving cow’s milk-based formula or fortifiers
    • Families who have experienced a premature infant death from NEC and may not know there is a reporting gap at the regulatory level
    • NICU clinicians and hospitals whose informed consent discussions about formula feeding may not have reflected the manufacturer’s internal awareness of NEC-related adverse events
    • Policymakers and advocates working on infant formula regulation reform

    Symptoms of NEC in Premature Infants

    Necrotizing enterocolitis typically develops in premature infants two to four weeks after birth, often around the time feedings begin. Warning signs that require immediate evaluation by the neonatal team include:

    • Sudden abdominal swelling or rigidity
    • Feeding intolerance after previously tolerating feeds
    • Bloody stool
    • Temperature instability
    • Lethargy or decreased responsiveness
    • Skin discoloration over the abdomen

    If your premature infant is in the NICU, ask the neonatal team specifically about NEC risk and what the protocol is for early detection.

    What You Can Do Now

    • If your premature infant is currently in a NICU, ask the neonatologist whether your baby is receiving human donor milk or cow’s milk-based formula, and what the facility’s protocol is for NEC monitoring.
    • Ask about your baby’s NEC risk based on gestational age and birth weight — infants born before 32 weeks and those under 1,500 grams face the highest risk.
    • Inquire about human milk availability at the facility. The American Academy of Pediatrics recommends human milk — including pasteurized donor milk — as the preferred nutrition for very premature infants.
    • If your premature infant previously suffered NEC while receiving cow’s milk-based formula, you may wish to consult a legal professional about your options. As of June 2026, active multidistrict litigation is proceeding in the Northern District of Illinois.
    • Report adverse events through the FDA’s MedWatch program if you believe a formula product contributed to a serious adverse event in your infant.

    Cost and Access: What Patients Should Know

    Human donor milk is more expensive than cow’s milk-based formula, and insurance coverage varies. NICU families should ask the billing department and the neonatology team about donor milk access and coverage. Many NICUs absorb donor milk costs for the highest-risk infants.

    For families who believe their infant was harmed by formula, legal consultations are typically offered at no upfront cost by firms handling NEC formula litigation. The Pancreatic Cancer Action Network NICHD page on NEC and infant feeding provides a recent scientific overview of the evidence.

    What Happens Next

    The KFF Health News investigation is expected to prompt renewed regulatory scrutiny of infant formula adverse event reporting requirements. The ongoing multidistrict litigation will produce additional bellwether trials in 2026 that may increase pressure on Abbott and Mead Johnson to consider broader settlements.

    Congress has shown some interest in strengthening formula safety oversight following the 2022 Abbott infant formula shortage and contamination recall. Whether the KFF Health News reporting prompts legislative action on adverse event reporting requirements remains to be seen.

    The Bottom Line

    The FDA received zero death notifications from infant formula manufacturers going back to the year 2000, according to FOIA records obtained by KFF Health News — confirmed by Abbott’s own expert witness, who testified the company never made a single such report for preterm formula. Approximately 2,300 premature infants died of NEC in the U.S. between 2017 and 2023. The combination of those two facts is not proof of causation — but it is a documented regulatory gap that left families fighting for accountability in court with no independent government safety record to draw on.

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  • The FDA Just Approved a Powerful Biologic for Children as Young as 6 with Severe Psoriasis or Psoriatic Arthritis

    The FDA Just Approved a Powerful Biologic for Children as Young as 6 with Severe Psoriasis or Psoriatic Arthritis

    Children as young as 6 years old with moderate-to-severe plaque psoriasis or active psoriatic arthritis now have access to one of the most effective biologics in dermatology and rheumatology, following an FDA approval announced June 26, 2026.

    AbbVie announced that the FDA has approved risankizumab (Skyrizi) for children 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and for active psoriatic arthritis in the same age group. A new 55 mg prefilled syringe was simultaneously approved to support weight-based dosing for patients weighing less than 40 kg, filling a critical gap in pediatric treatment access.

    Risankizumab is now the first and only interleukin-23 (IL-23) inhibitor approved in the United States for pediatric patients 6 years of age and older who weigh less than 40 kg with either plaque psoriasis or psoriatic arthritis.

    Why This Matters

    According to Drug Topics, approximately 30 percent of people who develop psoriasis first experience symptoms before age 18. For these patients, severe psoriatic disease can mean painful, visible skin lesions that affect school participation, social development, and mental health in addition to causing physical discomfort.

    Psoriatic arthritis in children — called juvenile psoriatic arthritis or psoriatic juvenile idiopathic arthritis — causes joint pain, swelling, and stiffness that can impair a child’s ability to walk, write, or participate in normal childhood activities. Before biologics in this class were available for children, treatment options were more limited, and some children were treated off-label with adult formulations in adult doses, which is not ideal from a pharmacokinetic standpoint.

    “Plaque psoriasis and psoriatic arthritis can affect much more than skin and joints — these conditions can shape daily life and disrupt important childhood experiences,” said Roopal Thakkar, MD, executive vice president of research and development at AbbVie.

    What We Know So Far

    Risankizumab is a humanized IgG1 monoclonal antibody that selectively blocks the p19 subunit of IL-23, a cytokine that drives the inflammatory cascade responsible for the skin plaques and joint inflammation in psoriatic disease. It was first approved for adults with moderate-to-severe plaque psoriasis in 2019 and has since received approvals for adult psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

    The pediatric approval is supported by data from the Phase 3 OptIMMize clinical trial program, which enrolled children and adolescents aged 6 through 17. Key findings from the trial:

    In adolescents aged 12 to 17: At week 16, 85.2 percent of risankizumab-treated patients achieved PASI75 (75% reduction in psoriasis severity), comparable to ustekinumab (85.7%). However, PASI100 (complete clearance) favored risankizumab at 40.7% versus 17.9% for ustekinumab.

    In children aged 6 to 11: Response rates at week 16 were high: PASI75 in 86.7%, PASI90 in 76.7%, and PASI100 (complete clearance) in 43.3%. Nearly all patients (90.0%) achieved a physician global assessment score of clear or almost clear.

    Durability: In adolescents who responded and continued treatment through week 52, approximately 95% maintained clear or almost clear skin — a strong durability finding for this age group.

    The safety profile in pediatric patients was consistent with the established adult safety profile, according to AbbVie and Contemporary Pediatrics.

    Who Qualifies for Skyrizi — Children and Dosing

    Age: 6 years and older

    Conditions: Moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; OR active psoriatic arthritis

    Dosing by weight:

    • Children weighing less than 40 kg: 55 mg subcutaneous injection (new weight-based formulation)
    • Children weighing 40 kg or more: 150 mg subcutaneous injection (same as adult dosing)

    Administration schedule: An initial dose, followed by a dose 4 weeks later, then maintenance dosing every 12 weeks thereafter — the same schedule used in adults.

    The psoriatic arthritis approval for children 6 and older is supported by the OptIMMize psoriasis data plus population pharmacokinetic modeling from well-controlled adult PsA studies.

    What Doctors and Experts Say

    Amy S. Paller, MD, chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine and a lead OptIMMize study investigator, called the approval significant: “These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with these conditions.”

    Medscape’s analysis noted that this is the first IL-23 inhibitor to reach the under-40 kg pediatric population, distinguishing Skyrizi from other biologics in this class that have not yet reached this weight category in children.

    What the Evidence Shows — and What It Does Not

    MedicalDaily Evidence Check

    • Study type: Phase 3 randomized controlled trial (OptIMMize psoriasis program) — active-controlled in adolescents; single-arm open-label in children 6 to 11
    • Participants: Children and adolescents aged 6–17 with moderate-to-severe plaque psoriasis; PsA approval additionally supported by adult data plus PK modeling
    • Published in: Journal of Investigative Dermatology (conference data); FDA review completed June 26, 2026
    • What it found: High rates of PASI75, PASI90, and PASI100 at week 16 with durable responses through week 52
    • Key limitation: The psoriatic arthritis approval for children is partially supported by adult study data extrapolation through PK modeling rather than a dedicated pediatric PsA efficacy trial
    • Safety limitation noted: Detailed pediatric adverse event rates and serious adverse event rates were not publicly released in the press announcement

    What You Can Do Now

    • If your child has moderate-to-severe plaque psoriasis or psoriatic arthritis that has not been adequately controlled with topical therapies, ask your pediatric dermatologist or pediatric rheumatologist about risankizumab at your next appointment.
    • Before starting any biologic, standard screening includes tuberculosis testing, hepatitis B testing, and a review of current infections — discuss these with your child’s specialist.
    • The European Commission approved risankizumab for pediatric plaque psoriasis (ages 6 and up) on June 23, 2026 — just days before the U.S. approval — making this a global regulatory milestone for pediatric psoriatic disease.

    Cost and Access: What Patients Should Know

    Skyrizi is a biologic specialty medication. Insurance coverage and prior authorization requirements vary by plan. AbbVie has a patient support program — myAbbVie Assist — for eligible patients who need help with access or cost. Contact your specialty pharmacy or AbbVie’s patient support team for current assistance program details.

    The Bottom Line

    Skyrizi (risankizumab) is now FDA-approved for children 6 and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis — making it the first and only IL-23 inhibitor available for the under-40 kg pediatric population in the United States. Clinical trial data showed high rates of complete skin clearance in both adolescents and younger children, with durable responses through a year of treatment. Families of children with severe psoriatic disease should ask their pediatric specialist whether risankizumab is appropriate.

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  • June Brought Two Major FDA Advances for Children with Type 1 Diabetes: Here’s What Each One Does

    June Brought Two Major FDA Advances for Children with Type 1 Diabetes: Here’s What Each One Does

    June 2026 brought two separate FDA decisions that, together, represent a meaningful shift in how children with Type 1 diabetes can be monitored and treated.

    On June 12, the FDA cleared the Dexcom Stelo continuous glucose monitor (CGM) for over-the-counter use in children as young as 2 years old — the first OTC CGM ever cleared for a pediatric population. And also on June 12, the FDA granted accelerated approval to teplizumab (Tzield; Sanofi) for a new indication: slowing the loss of insulin production in children and adolescents aged 8 to 17 who were recently diagnosed with Stage 3 Type 1 diabetes.

    These two developments address different stages and aspects of the same disease, one making it easier for families to track glucose levels without a prescription, and the other giving newly diagnosed children a disease-modifying therapy option that did not exist before.

    Why This Matters

    Type 1 diabetes is a lifelong autoimmune disease in which the immune system destroys the insulin-producing beta cells of the pancreas. An estimated 1.9 million Americans live with Type 1 diabetes, with a significant share diagnosed in childhood. Unlike Type 2 diabetes, Type 1 has no lifestyle-driven cause and no cure. Management has historically consisted entirely of insulin replacement, keeping glucose levels in range through multiple daily injections or an insulin pump, guided by continuous glucose monitoring.

    These two approvals change what is available to families. One makes glucose monitoring more accessible without the barrier of a prescription or insurance prior authorization. The other introduces the first therapy that targets the disease’s underlying mechanism — the autoimmune destruction of beta cells — rather than simply replacing what those cells would have produced.

    The OTC Children’s CGM: What the Stelo Clearance Means

    According to HCPLive reporting on the June 12 FDA announcement, the FDA cleared Dexcom’s Stelo Glucose Biosensor System for OTC use in children aged 2 and older who do not use insulin. This expands a clearance that previously existed for adults without insulin use.

    The Stelo is designed for real-time blood glucose monitoring without the need for a prescription. It can be purchased directly by consumers and is intended for children managing blood sugar through diet, exercise, and oral medications, as well as those who want to understand how food and physical activity affect glucose levels.

    “Children deserve access to the best tools available to manage their health,” said Michelle Tarver, MD, PhD, Director of the FDA’s Center for Devices and Radiological Health, in the agency’s announcement. “Today’s clearance reflects the FDA’s commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play.”

    This is an important distinction: the Stelo OTC clearance is for children not currently on insulin. Children with Type 1 diabetes using insulin will continue to use prescription-level CGMs (like the Dexcom G7) that integrate with insulin pumps and have more intensive monitoring features. The OTC clearance primarily benefits children with Type 2 diabetes or prediabetes — and those at risk for blood sugar fluctuations from other causes — whose families have previously faced barriers accessing CGM technology without a prescription.

    Teplizumab for Stage 3 Type 1 Diabetes: The First Disease-Modifying Treatment

    The FDA’s June 12, 2026 accelerated approval of teplizumab (Tzield) for Stage 3 Type 1 diabetes in patients aged 8 to 17 is the more clinically transformative of the two decisions.

    What the stages mean: Type 1 diabetes is a staged disease. Stage 1 is the presence of autoantibodies with normal glucose. Stage 2 is autoantibodies plus dysglycemia (abnormal glucose levels but no clinical symptoms). Stage 3 is the onset of clinical diabetes — the point at which symptoms appear and insulin treatment begins.

    What teplizumab does: Teplizumab is an anti-CD3 monoclonal antibody. It works by targeting and partially exhausting the autoimmune T cells that attack and destroy the insulin-producing beta cells in the pancreas. By limiting this autoimmune destruction, teplizumab preserves residual beta cell function, allowing the pancreas to continue producing some insulin even after diagnosis.

    The pivotal PROTECT trial enrolled 328 newly diagnosed Type 1 patients aged 8 through 17 within six weeks of diagnosis. Participants received two 12-day infusion courses — one at baseline and one at 26 weeks. Those who received teplizumab showed significantly better preservation of beta cell function, measured by stimulated C-peptide levels at 78 weeks, compared to placebo.

    According to Patient Care Online, Mahtab Niyyati, MD, acting associate director at the FDA’s Division of Diabetes, Lipid Disorders and Obesity, stated: “Based on robust evidence of safety and effectiveness, this accelerated approval provides a chance for pediatric patients with recently diagnosed Stage 3 type 1 diabetes to alter the course of their disease.”

    What Preserved Beta Cell Function Means Clinically

    Teplizumab does not cure Type 1 diabetes. Children who receive it still need insulin. But preserving some residual beta cell function — even for one to two years longer than without treatment — is clinically meaningful in several ways:

    • Lower insulin requirements
    • Better glycemic control with less hypoglycemia (dangerous low blood sugar)
    • A longer window of the “honeymoon period,” when some natural insulin production reduces the intensity of insulin management

    The Pediatric Endocrine Society notes that the drug is given as a 14-consecutive-day IV infusion cycle at baseline and again at 26 weeks, and that prescribers must monitor for Epstein-Barr virus and cytomegalovirus reactivation, cytokine release syndrome in the first five days, and transient drops in lymphocytes and neutrophils.

    The approval is accelerated, meaning a post-marketing confirmatory study is required.

    Where Teplizumab Has Been and Where It Is Going

    Teplizumab was first FDA-approved in November 2022 for individuals aged 8 and older with Stage 2 Type 1 diabetes — to prevent or delay progression to Stage 3. In April 2026, that Stage 2 indication was extended to children as young as 1 year old. The June 2026 action is the first approval for Stage 3 disease, meaning teplizumab can now be used across multiple stages of T1D in pediatric patients.

    This progression matters: it means a child could potentially receive teplizumab at Stage 2 to delay clinical onset, and again at Stage 3 to preserve beta-cell function after diagnosis.

    Who Qualifies for Each Approval?

    Dexcom Stelo OTC CGM: Children aged 2 and older who do not use insulin. No prescription required. Available for purchase directly by consumers.

    Teplizumab (Tzield) for Stage 3 T1D: Children and adolescents aged 8 to 17 who have been recently diagnosed (within 6 weeks) with Stage 3 Type 1 diabetes. Administered by infusion in a clinical setting. Requires a physician’s prescription and monitoring for adverse effects.

    What You Can Do Now

    • If you are the parent of a child with Type 2 diabetes or prediabetes, talk to your pediatrician or endocrinologist about whether the Dexcom Stelo OTC CGM is appropriate for monitoring your child’s glucose levels.
    • If your child has been recently diagnosed with Type 1 diabetes (within the past six weeks) and is between 8 and 17 years old, ask their pediatric endocrinologist about teplizumab (Tzield) and whether they are a candidate for treatment.
    • If your child was previously diagnosed with Type 1 diabetes more than six weeks ago, they likely fall outside the current approval window for Stage 3 teplizumab, but your endocrinologist can advise on whether clinical trial participation is an option.

    Cost and Access: What Patients Should Know

    The Dexcom Stelo OTC CGM can be purchased without a prescription at major retailers and online. Without insurance, the cost of CGM sensors is approximately $90 to $100 per month. Some insurance plans cover OTC CGMs, but coverage varies — check with your insurer.

    Teplizumab (Tzield) is an infusion drug that requires administration in a clinical setting. Insurance coverage for teplizumab has historically been a significant access barrier. Sanofi has a patient assistance program for eligible patients; families should contact their endocrinologist or the manufacturer for current access program details.

    What Happens Next

    The accelerated approval for teplizumab in Stage 3 requires a post-marketing confirmatory study. Sanofi has ongoing clinical research programs. The OTC CGM market for children is likely to expand as additional manufacturers seek similar clearances. MedicalDaily will report on confirmatory study results and any guideline updates from the American Diabetes Association or Pediatric Endocrine Society.

    The Bottom Line

    June 2026 delivered two meaningful changes for children living with Type 1 diabetes and those at risk. A prescription barrier for glucose monitoring in non-insulin-dependent children has been removed with the OTC CGM clearance. And for newly diagnosed children ages 8 to 17, teplizumab is now the first FDA-approved therapy that targets the autoimmune destruction underlying their disease, not just its metabolic consequences. Families should discuss both developments with their pediatric endocrinologist.

    References

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  • FDA Approves Xocova (Ensitrelvir): The First Oral COVID Pill You Take After Exposure — Before You Get Sick

    FDA Approves Xocova (Ensitrelvir): The First Oral COVID Pill You Take After Exposure — Before You Get Sick

    COVID-19 is still killing tens of thousands of Americans every year — and for the first time, there is now an FDA-approved oral medication that household contacts of infected individuals can take before symptoms develop to significantly reduce their risk of getting sick.

    On June 1, 2026, the U.S. Food and Drug Administration approved Xocova® (ensitrelvir), an oral antiviral developed by Japanese pharmaceutical company Shionogi, for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents 12 years of age and older. It is the first and only oral option approved for preventing COVID-19 after exposure to an infected individual — a distinct and previously unaddressed clinical need.

    What Xocova Is — and How It Differs From Paxlovid

    The distinction between Xocova and Paxlovid (nirmatrelvir/ritonavir) is essential to understand, because they serve different purposes at different points in the COVID-19 timeline.

    Paxlovid is taken after a positive COVID test and symptom onset, to reduce the severity of illness in high-risk individuals who are already sick. It is a treatment for active disease.

    Xocova is taken after exposure to an infected individual, before the person becomes infected or symptomatic — a pre-symptomatic intervention window that previously had no oral pharmacological option in the United States. It is a prophylactic medication, not a treatment for existing infection.

    Mechanistically, both drugs target the same SARS-CoV-2 main protease (3CL protease) — a key enzyme the virus needs to replicate. By blocking this enzyme, Xocova prevents the virus from reproducing efficiently in newly exposed individuals, reducing the probability that a household exposure leads to established infection.

    According to the SCORPIO-PEP trial data published in the New England Journal of Medicine: in the primary endpoint analysis of 2,041 SARS-CoV-2-negative participants, only 2.9% of those in the ensitrelvir group developed symptomatic COVID-19 by day 10, compared with 9.0% in the placebo group — a 67% reduction in risk.

    Xocova (Ensitrelvir) Key Data Detail
    FDA approval date June 1, 2026
    Developer Shionogi (Japan)
    Indication Post-exposure prophylaxis (PEP) of COVID-19
    Age indication Adults and adolescents 12 years and older
    Phase 3 trial SCORPIO-PEP (NCT05897541)
    Primary endpoint result 67% lower risk of symptomatic COVID-19 (2.9% vs. 9.0%)
    Secondary analysis (all participants) 57% risk reduction
    Dosing regimen 375mg on Day 1 (3 tablets); then 125mg on Days 2–5 (1 tablet each)
    Duration 5 days
    Most common side effects Headache, diarrhea, cough (15.1% vs. 15.5% placebo)
    Prior approved COVID post-exposure option None (bamlanivimab withdrawn due to Omicron resistance)
    U.S. COVID cases Oct 2025 – May 2026 3.8–12.4 million (CDC estimate)
    U.S. COVID deaths Oct 2025 – May 2026 13,000–42,000 (CDC estimate)

    How the Trial Worked — and What the Results Mean

    The SCORPIO-PEP trial enrolled 2,387 individuals aged 12 and older who had tested negative for SARS-CoV-2 at enrollment and were living in a household with a confirmed COVID-19 case. Participants were randomized 1:1 to receive ensitrelvir or matching placebo for five days.

    According to AJMC, ensitrelvir was well tolerated — adverse event rates were nearly identical between the ensitrelvir group (15.1%) and placebo group (15.5%), with the most common events being headache, diarrhea, and cough. No serious safety signals were identified.

    A notable feature of the trial population: more than 99% of household contacts already had SARS-CoV-2 antibodies at baseline — meaning nearly the entire study population had pre-existing immunity from prior infection, vaccination, or both. TechTimes noted that the drug performed equally well in this highly immune population, confirming that Xocova’s benefit does not depend on immunological naivety. This is clinically significant: it means the medication is likely to work in 2026’s real-world population, nearly all of whom have some prior COVID immunity.

    Who Should Take Xocova — and When

    The critical timing parameter for Xocova is not yet formally defined by the FDA label as a specific hour cutoff, but the clinical logic — and the trial design — centers on initiating treatment as soon as possible after a confirmed household exposure, ideally within 24 to 72 hours.

    The populations with the most to gain include:

    • Adults 60 and older, who remain at highest risk of severe COVID outcomes
    • Immunocompromised individuals (transplant recipients, patients on chemotherapy, people with HIV, those on long-term immunosuppressive therapy)
    • Adults with significant comorbidities — heart disease, diabetes, chronic kidney disease, chronic lung disease, obesity
    • Residents and staff of long-term care facilities, where up to 47% of household-level contacts develop COVID following exposure to an infected person, according to Shionogi’s prescribing data
    • Adolescents 12 and older in high-risk households

    Anyone in one of these groups who has a confirmed household contact with COVID-19 should contact their healthcare provider immediately to discuss Xocova eligibility. The drug closes a therapeutic gap that has existed since bamlanivimab/etesevimab — the only prior authorized COVID post-exposure option — was withdrawn after proving ineffective against Omicron variants.

    “The approval for COVID-19 PEP was based on data from the SCORPIO-PEP trial, which demonstrated favorable safety and efficacy in uninfected pediatric and adult patients who had been exposed to an infected individual, reducing the risk of symptomatic COVID-19 by 67%,” AJMC reported.

    COVID-19 in 2026 — Why This Still Matters

    The approval arrives at a moment when COVID-19 has become background noise for many Americans but remains a significant cause of illness, hospitalization, and death. The CDC estimates that between October 1, 2025, and May 23, 2026, there were 3.8 to 12.4 million new COVID cases in the United States, resulting in 800,000 to 2.3 million outpatient visits, 120,000 to 240,000 hospitalizations, and 13,000 to 42,000 deaths. Long COVID — which produces lasting neurological, cardiovascular, and respiratory complications — adds a further layer of risk that prevention reduces. Preventing even a percentage of those infections among the highest-risk population represents a meaningful public health gain.

    Frequently Asked Questions

    What is Xocova (ensitrelvir) and what was it approved for?

    Xocova (ensitrelvir) was FDA-approved June 1, 2026, by Shionogi, as the first and only oral medication for post-exposure prophylaxis (PEP) of COVID-19. It is approved for adults and adolescents 12 and older who have had contact with a confirmed COVID-19 case.

    How is Xocova different from Paxlovid?

    Paxlovid is taken after a positive COVID test and symptom onset to reduce disease severity. Xocova is taken after exposure but before infection or symptom onset, to prevent the exposed person from developing COVID at all. They target the same viral enzyme but are used at different clinical moments.

    How effective is Xocova?

    In the Phase 3 SCORPIO-PEP trial, Xocova reduced the risk of symptomatic COVID-19 by 67% compared to placebo in household contacts who were initially SARS-CoV-2-negative, with a secondary analysis showing 57% risk reduction across all participants.

    How do you take Xocova?

    Xocova is a 5-day oral regimen: 3 tablets taken as a single dose on Day 1, then 1 tablet per day on Days 2 through 5. It should be started as soon as possible after a confirmed household exposure. Contact your healthcare provider immediately if you have been exposed.

    Who qualifies for Xocova?

    The FDA approval covers adults and adolescents 12 and older following contact with a confirmed COVID-19 case. People most likely to benefit include adults 60 and older, the immunocompromised, those with significant comorbidities, and long-term care residents and staff. A healthcare provider should assess individual eligibility.

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  • First-in-Class Drug Targeting Treatment-Resistant High Blood Pressure Wins FDA Approval — and Works Like No Existing Drug

    First-in-Class Drug Targeting Treatment-Resistant High Blood Pressure Wins FDA Approval — and Works Like No Existing Drug

    High blood pressure — hypertension — is the single most treatable risk factor for cardiovascular disease and stroke, the two leading causes of death in the United States. There are already more than a dozen classes of antihypertensive medications. For most patients, combining two or three of these drugs in appropriate doses achieves adequate blood pressure control and dramatically reduces the risk of heart attack, stroke, kidney failure, and premature death.

    But for a significant subset — estimated at 10 to 15 percent of all hypertensive patients — blood pressure remains uncontrolled despite taking two, three, or even four medications at maximum tolerated doses. This is called resistant hypertension, and it represents one of the most clinically frustrating situations in internal medicine: a patient taking a handful of pills every day, experiencing their side effects, and still not achieving the blood pressure target that determines their future risk of cardiovascular catastrophe.

    For these patients, the FDA’s May 18, 2026 approval of baxdrostat (Baxfendy) — developed by AstraZeneca — represents the arrival of a fundamentally new therapeutic option built on a mechanism of action that no previously approved drug has ever targeted in this indication.

    “We have been waiting for an innovative medication like BAXFENDY for hypertension for many years,” said Bryan Williams, MD, Chair of Medicine at University College London and a primary investigator for the pivotal BaxHTN trial. “Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension.”

    The Aldosterone Problem and Why Existing Drugs Miss It

    Aldosterone is a steroid hormone produced by the adrenal glands that regulates sodium and water retention in the kidneys. When aldosterone levels are excessive — whether due to a benign adrenal tumor (primary aldosteronism), stress-related overproduction, or other dysregulation — the kidneys retain too much sodium and water, blood volume rises, and blood pressure increases in a way that does not respond well to most standard antihypertensive mechanisms.

    The renin-angiotensin-aldosterone system (RAAS) is already a major target of existing hypertension drugs: ACE inhibitors, ARBs, and direct renin inhibitors all interfere with the pathway that leads to aldosterone production. But these drugs do not directly target aldosterone synthase — the specific enzyme, encoded by the CYP11B2 gene, that is the final step in aldosterone manufacturing in the adrenal gland. Blocking earlier steps in the RAAS leaves aldosterone synthase activity largely intact, allowing it to produce aldosterone through compensatory mechanisms.

    Baxdrostat is a selective aldosterone synthase inhibitor — a small-molecule oral drug that directly and selectively inhibits CYP11B2, preventing aldosterone from being synthesized in the first place. This selectivity is critical: the enzyme CYP11B1, which produces cortisol and sits in a closely adjacent biochemical pathway, is not significantly affected by baxdrostat at therapeutic doses. This means baxdrostat lowers aldosterone — and therefore blood pressure — without disrupting the cortisol axis that regulates the stress response, immune function, and metabolism. AstraZeneca confirmed in clinical trials that baxdrostat lowered aldosterone levels without affecting cortisol levels.

    What the BaxHTN Phase 3 Trial Found

    The BaxHTN trial enrolled 796 patients with uncontrolled or resistant hypertension — all already on at least two antihypertensive agents, including a diuretic — and randomized them 1:1:1 to receive baxdrostat 2 mg once daily, baxdrostat 1 mg once daily, or placebo in addition to their background therapy, for 12 weeks.

    At week 12:

    • Patients on baxdrostat 2 mg had a 15.7 mmHg reduction in seated systolic blood pressure from baseline — a 9.8 mmHg placebo-adjusted reduction.
    • Patients on baxdrostat 1 mg had a 14.5 mmHg reduction — an 8.7 mmHg placebo-adjusted reduction.
    • The placebo group had a 5.8 mmHg reduction from baseline.

    Both doses met the primary endpoint of statistically significant systolic blood pressure reduction. The findings were consistent in patients with both uncontrolled hypertension (not at goal despite two or more drugs) and truly resistant hypertension (not at goal despite three or more drugs, including a diuretic). Results were also supported by a separate Phase 3 Lancet-published Bax24 trial using ambulatory blood pressure monitoring, confirming the effect on 24-hour blood pressure rather than only the clinic reading.

    A 9.8 mmHg reduction in systolic blood pressure is not a cosmetic number. Systematic reviews of blood pressure interventions consistently show that each 5 mmHg reduction in systolic blood pressure reduces the risk of major cardiovascular events by approximately 10 percent. For patients whose blood pressure has been inadequately controlled despite multiple medications — meaning they have been living with elevated cardiovascular risk despite treatment — a nearly 10 mmHg additional reduction is clinically meaningful and potentially life-extending.

    Who Will Benefit and What Comes Next

    Baxfendy is approved as an add-on oral treatment for adults with hypertension not adequately controlled on other medications. It is taken once daily in 1 mg or 2 mg doses. The key safety considerations identified in trials are hyperkalemia (elevated blood potassium), which requires periodic monitoring, and hyponatremia (low sodium) in some patients. Neither was dose-limiting in the vast majority of trial participants.

    The drug received Fast Track and Breakthrough Therapy designations from the FDA during development, signaling the agency’s recognition of the unmet need it addresses. AstraZeneca is also studying baxdrostat in additional conditions where aldosterone excess plays a mechanistic role, including chronic kidney disease and heart failure — conditions that frequently co-occur with resistant hypertension.

    Frequently Asked Questions

    Q: What is baxdrostat (Baxfendy) and who is it for?

    A: Baxdrostat is the first-ever oral aldosterone synthase inhibitor, FDA-approved May 18, 2026 as an add-on treatment for adults with hypertension not adequately controlled on other antihypertensive medications.

    Q: How does baxdrostat work differently from other blood pressure drugs?

    A: It directly and selectively inhibits aldosterone synthase (the CYP11B2 enzyme), preventing aldosterone production at its source. No previously approved drug has targeted this specific enzyme. Existing RAAS drugs act earlier in the pathway and leave aldosterone synthase partially active.

    Q: How much does baxdrostat lower blood pressure?

    A: In the BaxHTN Phase 3 trial, baxdrostat 2 mg added to background therapy produced a 9.8 mmHg placebo-adjusted reduction in systolic blood pressure at 12 weeks. The 1 mg dose achieved an 8.7 mmHg reduction.

    Q: Does baxdrostat affect cortisol levels?

    A: No. Baxdrostat selectively inhibits CYP11B2 (aldosterone synthase) without significantly affecting CYP11B1 (cortisol synthesis). Clinical trials confirmed aldosterone reductions without changes in cortisol.

    Q: What are the main side effects of baxdrostat?

    A: Hyperkalemia (elevated potassium) and hyponatremia (low sodium) are the primary safety considerations, both requiring periodic monitoring. Neither was dose-limiting in most trial participants.

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  • FDA Approves New Immunotherapy Combination for High-Risk Early-Stage Bladder Cancer

    FDA Approves New Immunotherapy Combination for High-Risk Early-Stage Bladder Cancer

    The U.S. Food and Drug Administration (FDA) has approved a new treatment option for patients with high-risk non–muscle invasive bladder cancer (NMIBC), authorizing the use of durvalumab (Imfinzi) in combination with Bacillus Calmette-Guérin (BCG) on May 28, 2026. The decision represents an expansion of immunotherapy-based treatment strategies for a disease known for its high recurrence rate and long-term management needs.

    NMIBC is the most common form of bladder cancer and is characterized by tumors confined to the bladder’s inner lining without invading the muscle layer. Although generally less aggressive than muscle-invasive disease, it frequently recurs after treatment and, in some cases, can progress, requiring ongoing surveillance and repeated intervention.

    The approval is supported by data from the Phase 3 POTOMAC trial (NCT03528694), a randomized, multicenter study evaluating durvalumab plus BCG versus BCG alone in patients with high-risk NMIBC who had undergone transurethral resection of bladder tumor (TURBT).

    The trial enrolled more than 1,000 patients and followed participants after TURBT, with the primary endpoint defined as investigator-assessed disease-free survival (DFS), measuring recurrence, progression to muscle-invasive or metastatic disease, or death.

    Results showed that the durvalumab combination reduced the risk of disease recurrence, progression, or death by 32% compared with BCG alone (hazard ratio 0.68; 95% CI 0.50–0.93). Median disease-free survival was not reached in either group at the time of analysis.

    Researchers also reported fewer DFS events in the combination arm, with 67 events compared with 98 events in the BCG-only group, suggesting improved disease control with the addition of durvalumab.

    Durvalumab is an immune checkpoint inhibitor that blocks PD-L1, helping the immune system recognize and attack cancer cells more effectively. BCG, a long-established intravesical therapy for bladder cancer, stimulates a localized immune response within the bladder to target residual tumor cells.

    The combination is designed to enhance both systemic and local immune activity, with the goal of improving durable tumor control and reducing recurrence risk in high-risk patients.

    According to the FDA’s approval summary, the findings demonstrate a clinically meaningful improvement in disease-free survival, reinforcing the need for additional effective options beyond BCG alone in this patient population.

    With the approval, durvalumab plus BCG becomes an available treatment option for eligible patients with high-risk NMIBC. However, clinicians emphasize that routine cystoscopic surveillance remains essential, as recurrence risk persists even after therapy.

    Experts note that while the approval represents a significant advance in early-stage bladder cancer treatment, longer follow-up is still required to fully assess the durability of the benefit and its impact on overall survival outcomes.

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  • FDA Cracks Down on Whipped Sunscreens, Citing Lack of Approval and Safety Concerns

    FDA Cracks Down on Whipped Sunscreens, Citing Lack of Approval and Safety Concerns

    The US Food and Drug Administration (FDA) is warning consumers to avoid sunscreens sold in whipped, mousse, or foam forms, saying these products are not approved and could be unsafe.

    The agency recently sent warning letters to several companies, including Supergoop!, Vacation Inc., Kalani Sunwear, Botao Baby, and Tizo Skin, for marketing sunscreens in these unconventional formats.

    “These products might not be effective,” the FDA said in a post on X, emphasizing that whipped or mousse sunscreens have not been approved as safe or reliable for preventing sunburn or reducing skin cancer risk.

    The agency classifies these products as drugs because they are designed to protect against harmful UV rays, yet they have not received the necessary FDA approval.

    The FDA also raised concerns about packaging. According to FoxBusiness, many whipped and mousse sunscreens are sold in containers resembling food items, which could lead to accidental ingestion, especially by children.

    Vacation Inc., for instance, markets its “Classic Whip Sunscreens” as “dessert for your skin,” prompting the FDA to label the products as misbranded.

    “Packaging drug products in containers that resemble food containers commonly used by adults and children can mislead consumers into mistaking the products for food,” the agency warned.



    FDA Issues Warning on Supergoop! Mousse Sunscreen

    Supergoop! received a similar warning for its “Play SPF 50 Body Mousse.”

    The company told CBS MoneyWatch it is working to resolve what it described as a “product labeling” matter with the FDA and remains committed to maintaining high standards of safety and efficacy, NY Post said.

    Kalani Sunwear temporarily pulled its mousse-format sunscreen from its U.S. website to comply with regulations, while Botao Baby and Tizo Skin have not yet responded to inquiries.

    The FDA treats sunscreens like over-the-counter drugs, which means they have strict rules about how they can be sold.

    Right now, only lotions, creams, gels, oils, pastes, butters, ointments, and sticks are considered safe and effective.

    Sunscreens in mousse, foam, or whipped forms need separate FDA approval, and none of the ones on the market have it yet.

    Back in 2019, the FDA updated its sunscreen guidelines to reflect the latest science, including rules about active ingredients, SPF limits, broad-spectrum protection, and allowed forms.

    The Skin Cancer Foundation supports these rules, emphasizing that ongoing review is important as new UV filters and application methods come out.

    For now, consumers should read sunscreen labels carefully and steer clear of mousse, foam, or whipped products until they get FDA approval.

    Originally published on vcpost.com

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  • RFK Jr. Is Giving Families ‘False Hope’ By Claiming He’ll Figure Out Cause of Autism by September, Former FDA Vaccine Head Warns

    RFK Jr. Is Giving Families ‘False Hope’ By Claiming He’ll Figure Out Cause of Autism by September, Former FDA Vaccine Head Warns

    Dr. Peter Marks, the former top vaccine official at the U.S. Food and Drug Administration (FDA), has criticized Health and Human Services Secretary Robert F. Kennedy Jr. for giving what he called “false hope” to families by claiming that the Trump administration will identify the cause of autism by September.

    Marks, who resigned earlier this month amid mounting frustration with Kennedy’s promotion of vaccine misinformation, appeared on CBS’s Face the Nation to challenge Kennedy’s recent assertion that a massive federal research initiative would soon pinpoint and eliminate the root causes of autism.


    Kennedy announced the effort through the National Institutes of Health. “By September we will know what has caused the autism epidemic and we will be able to eliminate those exposures,” he promised.

    “Giving people false hope is something you should never do,” Marks said in response to Kennedy’s announcement.

    “I don’t see any possible way [to get the answer that quickly],” Marks continued. “Autism is an incredibly complicated issue.”

    Kennedy, a longtime vaccine skeptic, has implied that vaccines may be among the environmental toxins driving autism rates. However, Marks dismissed that notion, citing the overwhelming body of research showing no link between vaccines and autism. “We’ve studied them in so many millions of children,” he said.

    The controversy comes amid a deadly resurgence of measles in the US, with three unvaccinated individuals—including two young girls from Seminole, Texas—dying in recent weeks. Measles had been declared eliminated from the U.S. in 2000, but new outbreaks have developed in certain under-vaccinated communities.

    Kennedy has offered only tepid support for the measles vaccine, telling CBS that “people should get the measles vaccine” but reiterating his opposition to mandates. He has also promoted unproven alternatives like vitamins and cod-liver oil.

    Marks blamed the recent pediatric measles deaths on Kennedy and his staff, describing it as “the epitome of an absolute needless death.”

    “These kids should get vaccinated—that’s how you prevent people from dying of measles,” Marks emphasized.

    In his resignation letter, Marks criticized Kennedy for spreading misinformation and undermining public trust in safe and effective vaccines.

    “Truth and transparency are not desired by the secretary,” Marks wrote. “He wishes subservient confirmation of his misinformation and lies.”

    Originally published on Latin Times



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  • Journavx, New Type Of Non-Opioid Pain Relief Drug Gets FDA Approval

    Journavx, New Type Of Non-Opioid Pain Relief Drug Gets FDA Approval

    The U.S. Food and Drug Administration (FDA) has approved Suzetrigine, a new non-opioid pain relief drug sold under the brand name Journavx, to treat moderate to severe acute pain in adults.

    Journavx from Vertex Pharmaceuticals marks the first new class of pain reliever to receive FDA approval in over two decades. It will be sold as 50-milligram prescription pills that work by blocking pain signals at their source by targeting sodium channels in the nervous system and stopping pain before it reaches the brain.

    “Today’s approval is an important public health milestone in acute pain management. A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management,” Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research said in a news release.

    Non-opioid pain relief is a crucial step forward in addressing the ongoing opioid crisis. With over 80 million Americans requiring pain relief, around half are prescribed opioids. However, nearly 10% of those initially prescribed opioids end up using them long-term, and about 85,000 develop opioid use disorder each year. Non-opioid alternatives offer a safer option for pain management, reducing the risk of dependency.

    According to the manufacturer, Journavx is a well-tolerated, effective pain reliever with no signs of addictive potential, designed for all types of moderate to severe acute pain.

    The efficacy of the drug was tested in two clinical trials involving surgical pain, one after tummy tuck surgery (abdominoplasty) and the other after bunion surgery. Participants were randomly given either Journavx or a placebo. If pain control was not enough, they could also take ibuprofen for extra relief. Both trials showed that Journavx worked significantly better than a placebo in reducing pain.

    The safety of Journavx was evaluated based on data from two main trials with 874 participants who had moderate to severe acute pain after a tummy tuck or bunion surgery, along with additional data from a smaller study with 256 participants in various acute pain conditions.

    The most common side effects reported were itching, muscle spasms, elevated creatine phosphokinase levels, and rash. Journavx should not be taken with strong CYP3A inhibitors, and patients should avoid grapefruit or grapefruit-containing foods and drinks while using it. The drug will be priced at $15.50 per 50mg pill.

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