FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 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 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 …

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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 …

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Published on September 19, 2025 - 20:52 GMT

FDA Grants Accelerated Approval to First Treatment for Barth Syndrome

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 10, 2025 - 14:35 GMT

FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse

For Immediate Release: September 10, 2025 Despite recent declines, opioids remain commonly prescribed to about 1 in 5 U.S. adults who live with chronic pain as effective alternatives are limited. As part of its broader strategy to address the opioid crisis …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 9, 2025 - 22:53 GMT

FDA Launches Crackdown on Deceptive Drug Advertising

For Immediate Release: September 09, 2025 The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements. Today, the FDA is …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 22, 2025 - 16:14 GMT

FDA Begins Real-Time Reporting of Adverse Event Data

For Immediate Release: August 22, 2025 Today, the U.S. Food and Drug Administration began daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS). This represents a significant step forward in modernizing the agency’s …

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Published on August 19, 2025 - 13:29 GMT

HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply

For Immediate Release: August 19, 2025 The U.S. Department of Health and Human Services (HHS) today issued a declaration that allows the U.S. Food and Drug Administration (FDA) to issue Emergency Use Authorizations (EUAs) for animal drugs to treat or …

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Published on August 14, 2025 - 23:07 GMT

FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis

For Immediate Release: August 14, 2025 Today, the U.S. Food and Drug Administration approved Papzimeos (zopapogene imadenovec-drba), a first-of-its-kind non-replicating adenoviral vector-based immunotherapy for the treatment of adult patients with …

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Published on August 13, 2025 - 19:07 GMT

Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products

For Immediate Release: August 13, 2025 Statement From: Martin A Makary, M.D., M.P.H. Commissioner of Food and Drugs - Food and Drug Administration Today I applaud Florida Attorney General James Uthmeier’s bold efforts to protect Floridians by filing an …

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Published on August 8, 2025 - 15:57 GMT

A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: Announcing Resolution of the IV Saline Solutions Shortage

For Immediate Release: August 08, 2025 Statement From: Martin A Makary, M.D., M.P.H. Commissioner of Food and Drugs - Food and Drug Administration I am pleased to announce that the nationwide shortage of sodium chloride 0.9% injection products, a form of …

Distribution channels: Healthcare & Pharmaceuticals Industry