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Tag: fda

  • 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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  • Eye Drops Recalled For Possible Fungal Contamination That May Affect Eyesight: FDA Warns

    Eye Drops Recalled For Possible Fungal Contamination That May Affect Eyesight: FDA Warns

    The U.S. Food and Drug Administration (FDA) has sounded the alarm on a nationwide recall of Systane brand eye drops, citing potential fungal contamination that could pose serious risks to eyesight.

    Systane Lubricant Eye Drops Ultra PF, commonly used to temporarily relieve burning and irritation caused by dry eye symptoms, is now at the center of a nationwide recall. The product was distributed to multiple retail stores and online platforms.

    Manufacturer Alcon Laboratories initiated the voluntary recall after a consumer reported foreign material inside a sealed single-use vial, which was later identified as fungal contamination.

    “Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients,” the FDA stated in a news release.

    The FDA has confirmed that no adverse events related to the recall have been reported so far. However, individuals experiencing quality issues or adverse reactions after using the product are encouraged to report them through the FDA’s MedWatch Adverse Event Reporting program. Complaints can be submitted online, by downloading and mailing the form, or via fax at 1-800-FDA-0178.

    Each cardboard box of the product contains 25 sterile, single-use vials of lubricant solution for ophthalmic use. “The affected Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count is limited to lot number 10101, expiration date 2025/09. The product can be identified by the green and pink carton design, the presence of “Systane” and “ULTRA PF” brand names on the front of the carton, and the “25 vials” package size,” the news release stated.

    Consumers who still have the products with them are advised to stop usage immediately and return to the place of purchase for a replacement or refund. Those who experience any issues potentially linked to the use of these eye drops should seek advice from a healthcare provider without delay.

    As Alcon conducts its investigation, a spokesperson told NBC News that “the presence of foreign material appears to be isolated to the single unit returned by a customer.” They emphasized that the recall is being carried out, “out of an abundance of caution to prioritize consumer safety.” Those who have issues with the product can also contact them at 800-241-5999.

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  • FDA Proposes To Ban Popular Decongestant In Cold Medicines Citing ‘Not Effective’

    FDA Proposes To Ban Popular Decongestant In Cold Medicines Citing ‘Not Effective’

    The U.S. Food and Drug Administration(FDA) has proposed to ban oral phenylephrine, an active ingredient in popular decongestants and cold medications, citing its lack of effectiveness.

    Several cold medications, including Advil, Vicks NyQuil, Sudafed PE, Robitussin, Benadryl Allergy Plus Congestion, Tylenol, and Theraflu, contain oral phenylephrine. In some, it is the only active ingredient, while others combine it with acetaminophen or dextromethorphan.

    Officials clarified that the proposed ban is unrelated to the safety of phenylephrine and does not affect the nasal spray form of phenylephrine.

    Companies may continue selling products containing oral phenylephrine until the order is finalized. The public can submit feedback on the FDA’s proposal until May 7, 2025. However, after this comment period, if the FDA finalizes its decision to revoke oral phenylephrine’s status as “generally recognized as safe and effective” (GRASE), manufacturers would need to either remove or reformulate products containing the ingredient. The FDA stated it would allow manufacturers an appropriate transition period in such cases.

    “It is the FDA’s role to ensure that drugs are safe and effective, Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) in a news release.

    Meanwhile, officials urge consumers to be mindful of the ingredients in over-the-counter (OTC) medications, advising them to read the drug facts label and follow important warnings and directions for use.

    “Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold. Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms,” said Dr. Theresa Michele, director of the Office of Nonprescription Drug Products in CDER.

    However, the Consumer Healthcare Products Association’s (CHPA) officials said they are “disappointed” with the proposed ban and maintained its position that “no changes to the GRASE status of oral PE (Phenylephrine) for nasal decongestion are warranted.”

    “PE should remain an available option for consumers because Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on,” CHPA said in a news release.

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  • FDA Wants To Further Reduce Salt Levels In Packaged, Processed Food

    FDA Wants To Further Reduce Salt Levels In Packaged, Processed Food

    The U.S. Food and Drug Administration has announced a milestone in its voluntary sodium reduction program by completing the Phase I target and issuing draft guidance for Phase II. In this next phase, the FDA plans to further reduce sodium levels in packaged and processed food by 20%, to bring the average intake to about 2,750 milligrams per day.

    According to the U.S. Dietary Guidelines, a person should not consume more than 2,300 milligrams of sodium per day, which is about one teaspoon of salt. The FDA launched its sodium reduction program in 2021, setting a 2.5-year target. The goal for Phase I was to lower the average daily sodium intake from 3,400 milligrams to 3,000 milligrams.

    High sodium intake is linked to health issues such as increased blood pressure, a major risk factor for heart disease and stroke. Studies have shown that reducing sodium intake could prevent hundreds of thousands of premature deaths and illnesses. However, to effectively lower sodium consumption, changes need to be made in the food supply itself, as more than 70 percent of sodium comes from processed and prepared foods.

    “Reducing sodium in the food supply has the potential to be one of the most important public health initiatives in a generation. The early successes we’re seeing with sodium level reduction in certain foods is encouraging and indicative of the impact we believe our overall nutrition approach can have on the wellbeing of society,” FDA Deputy Commissioner for Human Foods Jim Jones said in a news release.

    Phase II will continue to target sodium levels in commercially processed, packaged, and prepared foods in the marketplace.

    “In addition to our sodium reduction efforts, the FDA is also actively working on a forthcoming final rule updating the definition of the claim ‘healthy,’ a proposed rule for front-of-package nutrition labeling and exploring ways to reduce added sugars consumption. The FDA’s sodium reduction and other nutrition initiatives are central to a broader, whole-of-government approach to help reduce the burden of diet-related chronic diseases and advance health equity,” Jones added.

    The American Heart Association (AHA) advises limiting sodium intake to no more than 2,300 milligrams per day, with an ideal limit of 1,500 milligrams for those with high blood pressure. They suggest that reducing daily sodium intake by 1,000 milligrams can significantly improve blood pressure and heart health.

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