FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on December 15, 2025 - 20:33 GMT

FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula

For Immediate Release: December 15, 2025 The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 15, 2025 - 18:08 GMT

FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews

For Immediate Release: December 15, 2025 The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews. In new guidance for certain types of medical device …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 15, 2025 - 15:29 GMT

FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results

For Immediate Release: December 15, 2025 The U.S. Food and Drug Administration today awarded a national priority voucher to teclistamab in combination with daratumumab for relapsed/refractory multiple myeloma. This brings the total number of products …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 12, 2025 - 18:28 GMT

FDA Approves Two Oral Therapies to Treat Gonorrhea

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. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 24, 2025 - 22:32 GMT

FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2025 - 21:14 GMT

FDA Pilots Faster Clarifications to Meeting Minutes

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 14, 2025 - 19:01 GMT

FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury

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, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 12, 2025 - 09:06 GMT

FDA Proposes Expanding Sunscreen Active Ingredient List

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 11, 2025 - 21:57 GMT

Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 31, 2025 - 17:23 GMT

FDA Acts to Protect Children from Unapproved Fluoride Drug Products

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 29, 2025 - 18:44 GMT

FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 24, 2025 - 21:50 GMT

FDA Issues Emergency Use Authorization for New World Screwworm Drug for Dogs

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 23, 2025 - 14:51 GMT

FDA Publishes Filing Checklists to Prevent Submission Delays

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. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 16, 2025 - 21:31 GMT

FDA Awards First-Ever National Priority Vouchers to Nine Sponsors

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 11, 2025 - 12:30 GMT

HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 30, 2025 - 19:10 GMT

FDA Conditionally Approves First Drug for Prevention and Treatment of New World Screwworm Infestations in Cattle

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 30, 2025 - 13:31 GMT

A Statement From FDA Commissioner Marty Makary, M.D., M.P.H.: Encouraging Retailers to Stop Selling Illegal Vapes

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 25, 2025 - 18:27 GMT

FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 25, 2025 - 18:27 GMT

FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 22, 2025 - 21:22 GMT

FDA Takes Action to Make a Treatment Available for Autism Symptoms

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry