FDA Press Releases - EIN Presswire - Press Release Distribution Service

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

Published on September 22, 2025 - 21:22 GMT

FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 12, 2025 - 20:17 GMT

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 12, 2025 - 17:46 GMT

FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome

FDA News Release Agency exercises regulatory flexibility to address unmet need for rare, life-threatening disease For Immediate Release: December 09, 2025 The U.S. Food and Drug Administration today approved Waskyra (etuvetidigene autotemcel), the first …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 12, 2025 - 16:28 GMT

First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity

For Immediate Release: December 09, 2025 The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CNPV) pilot program, marking the first approval achieved …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 11, 2025 - 00:42 GMT

HHS, CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever Operation

For Immediate Release: September 10, 2025 The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7 million units of …

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry