FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 …

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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 …

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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 …

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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 …

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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 …

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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 12, 2025 - 13:02 GMT

FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia

For Immediate Release: December 08, 2025 The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). …

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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 …

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Published on July 31, 2025 - 19:51 GMT

FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks

FDA News Release Labeling change will affect all opioid pain medications and support more informed decision-making For Immediate Release: July 31, 2025 The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain …

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Published on July 29, 2025 - 14:55 GMT

FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers

FDA News Release Agency alerts health care professionals and consumers of 7-hydroxymitragynine risks For Immediate Release: July 29, 2025 The U.S. Food and Drug Administration today is taking a bold step to protect Americans from dangerous, illegal opioids …

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Published on July 28, 2025 - 20:46 GMT

FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients

For Immediate Release: July 28, 2025 The U.S. Food and Drug Administration is recommending the removal of the voluntary hold for ambulatory patients who may now receive Elevidys, a Sarepta Therapeutics gene therapy for Duchenne Muscular Dystrophy (DMD). …

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Published on July 25, 2025 - 22:42 GMT

FDA Investigating Death of 8-Year-Old Boy Who Received Elevidys

For Immediate Release: July 25, 2025 The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The …

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Published on July 23, 2025 - 22:18 GMT

HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods

For Immediate Release: July 23, 2025 Under the leadership of the U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. and the U.S. Department of Agriculture Secretary Brooke L. Rollins, the U.S. Food and Drug Administration and U.S …

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Published on July 22, 2025 - 19:55 GMT

HHS, FDA Praise Consumer Brands Association’s Vow to Remove Artificial Colors from America’s Food Supply

For Immediate Release: July 22, 2025 WASHINGTON – Today the leadership of the U.S. Department of Health and Human Services (HHS) praised the Consumer Brands Association for its pledge on behalf of the makers of the nation’s food and beverage products to …

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Published on July 21, 2025 - 11:23 GMT

Stanford faculty member George Tidmarsh, M.D., Ph.D. named Director of Center for Drug Evaluation and Research

For Immediate Release: July 21, 2025 The U.S. Food and Drug Administration today announced the appointment of George Francis Tidmarsh, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research (CDER). In this role, Dr. Tidmarsh will lead the …

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Published on July 18, 2025 - 23:07 GMT

FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy ...

For Immediate Release: July 18, 2025 The U.S. Food and Drug Administration today announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold following three deaths …

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Published on July 16, 2025 - 15:58 GMT

FDA to Revoke 52 Obsolete Standards of Identity for Food Products

FDA News Release Today’s action builds on Trump Administration’s deregulatory initiative. For Immediate Release: July 16, 2025 The U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding …

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