FDA News Release Approvals Are for Uncomplicated Urogenital Gonorrhea For Immediate Release: December 12, 2025 The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea …
For Immediate Release: November 24, 2025 The U.S. Food and Drug Administration today approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed …
For Immediate Release: November 19, 2025 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 …
For Immediate Release: November 14, 2025 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, …
For Immediate Release: December 11, 2025 Today, the U.S. Food and Drug Administration announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office of Nonprescription Drugs. The agency is proposing to add …
For Immediate Release: November 11, 2025 The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced that Richard Pazdur, M.D., has been appointed director of the Center for Drug Evaluation and …
For Immediate Release: October 31, 2025 The U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. The FDA sent notices to four companies outlining the …
For Immediate Release: October 29, 2025 The U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologic drugs that …
For Immediate Release: October 24, 2025 The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Credelio (lotilaner) chewable tablets, concluding that, based on the scientific evidence available, it is reasonable to …
For Immediate Release: October 23, 2025 The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable. …
For Immediate Release: October 16, 2025 The U.S. Food and Drug Administration today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. Each recipient has a product with significant potential to …
For Immediate Release: November 10, 2025 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 …
For Immediate Release: September 30, 2025 Today, the U.S. Food and Drug Administration conditionally approved Dectomax-CA1 (doramectin injection) injectable solution for the prevention and treatment of New World screwworm larval infestations, and …
For Immediate Release: September 30, 2025 Statement From: Martin A Makary, M.D., M.P.H. Commissioner of Food and Drugs - Food and Drug Administration As part of the FDA’s broader strategy to combat the crisis of youth vaping, we are launching an initiative …
FDA News Release Agency determines special restrictions are no longer necessary to ensure the benefits of thyroid cancer treatment with Caprelsa outweigh its risks For Immediate Release: September 25, 2025 The U.S. Food and Drug Administration today …
For Immediate Release: September 25, 2025 Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to slow the …
For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential …
FDA News Release Agency initiates safety label change and notifies physicians of possible link For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and …
FDA News Release New Treatment for Barth Syndrome Showcases FDA’s Commitment to Bringing Effective and Safe Medications to Patients in Need For Immediate Release: September 19, 2025 Today, the U.S. Food and Drug Administration granted accelerated approval …
For Immediate Release: September 12, 2025 The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s …
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