FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on March 3, 2026 - 18:40 GMT

FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s

For Immediate Release: March 03, 2026 The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false and misleading claims regarding compounded GLP-1 products offered on their websites. “ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 26, 2026 - 18:25 GMT

FDA Grants Second Approval under the National Priority Voucher Pilot Program

For Immediate Release: February 26, 2026 The U.S. Food and Drug Administration today issued an approval for the lung cancer drug Hernexeos (zongertinib) as a part of the new Commissioner's National Priority Voucher (CNPV) pilot program. The application …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 23, 2026 - 16:47 GMT

FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases

For Immediate Release: February 23, 2026 The U.S. Food and Drug Administration today issued draft guidance for sponsors seeking approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 12, 2026 - 17:23 GMT

FDA Approves Labeling Changes to Menopausal Hormone Therapy Products

For Immediate Release: February 12, 2026 The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 12, 2026 - 14:44 GMT

FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer

FDA News Release Device Delivers Non-invasive Therapy and Supports Care at Home For Immediate Release: February 12, 2026 The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 10, 2026 - 14:17 GMT

FDA Launches Assessment of BHA, a Common Food Chemical Preservative

For Immediate Release: February 10, 2026 The U.S. Food and Drug Administration today launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a chemical preservative used in food. The review will consider whether BHA is safe under its …

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Published on February 6, 2026 - 22:21 GMT

FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs

For Immediate Release: February 06, 2026 Statement From: Martin A Makary, M.D., M.P.H. Commissioner of Food and Drugs - Food and Drug Administration Today, the U.S. Food and Drug Administration is announcing its intent to take decisive steps to restrict …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 5, 2026 - 14:53 GMT

FDA Takes New Approach to "No Artificial Colors" Claims

FDA News Release Agency also grants two petitions to expand alternative food color options For Immediate Release: February 05, 2026 Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nation’s food supply …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 21, 2026 - 15:30 GMT

FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of Entry

FDA News Release New centralized program and technology upgrades dramatically enhance FDA’s ability to stop dangerous imports at U.S. borders For Immediate Release: January 21, 2026 The U.S. Food and Drug Administration today announced its initial review …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 21, 2026 - 15:04 GMT

FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods

For Immediate Release: January 21, 2026 Today, the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. The FDA is taking this action as a first step to improve …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 12, 2026 - 22:11 GMT

FDA Approves First Treatment for Children With Menkes Disease

For Immediate Release: January 12, 2026 The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. “With today’s action, children with this devastating, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 12, 2026 - 14:58 GMT

FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

For Immediate Release: January 12, 2026 The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2026 - 20:16 GMT

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

For Immediate Release: January 11, 2026 The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 2, 2026 - 10:13 GMT

FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing

FDA News Release Agency Now Accepting Requests to Participate in Initiative to Enhance Regulatory Predictability and Streamline New Manufacturing Facility Assessment For Immediate Release: February 01, 2026 The U.S. Food and Drug Administration today began …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 29, 2025 - 19:45 GMT

FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products

For Immediate Release: December 29, 2025 The U.S. Food and Drug Administration today released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and polyfluoroalkyl …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 19, 2025 - 22:31 GMT

FDA Grants Two National Priority Vouchers

For Immediate Release: December 19, 2025 The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase …

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Published on December 19, 2025 - 15:36 GMT

FDA Explores New Contracting Approach to Advance Public Health Innovation

For Immediate Release: December 19, 2025 The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between the agency and …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

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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 …

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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