Articles from FDA

White Oak, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT). The agency’s more flexible approach has been, and is expected to continue to be, helpful in expediting product development and will help guide the FDA’s evaluation of development strategies in preparation for a Biologics License Application (BLA) submission.  

Silver Spring, Md., Nov. 19, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. Through the program, sponsors are given a “Meeting Minute Clarification Opportunity” which gives them the opportunity to obtain a quick clarification of a response from a single discipline.

Silver Spring, Md., Nov. 14, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent safety warning, to Elevidys (delandistrogene moxeparvovec-rokl), and that the indication section of the labeling limits the therapy’s indication to ambulatory patients four years of age and older with Duchenne muscular dystrophy (DMD). These actions follow reports of fatal acute liver failure in non-ambulatory patients treated with the product.  

Washington, D.C., Nov. 10, 2025 (GLOBE NEWSWIRE) -- The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health. After more than two decades of fear and misinformation surrounding hormone replacement therapy (HRT), the U.S. Food and Drug Administration (FDA) is initiating the removal of broad “black box” warnings from HRT products for menopause.

Silver Spring, Md., Nov. 06, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program. This second cohort brings the total number of voucher recipients to 15, underscoring the agency's commitment to accelerating the review of products with the potential to address key national priorities.

Silver Spring, Md., Nov. 05, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. The agency is aware of adverse events associated with unapproved and misbranded botulinum toxin products, including botulism symptoms.