FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on May 12, 2025 - 15:24 GMT

FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies

For Immediate Release: December 05, 2025 The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 11, 2025 - 13:44 GMT

FDA Warns Companies Over Illegal Marketing of Botox and Related Products

For Immediate Release: November 05, 2025 The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. The agency is aware of adverse …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 9, 2025 - 17:34 GMT

FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children

For Immediate Release: September 05, 2025 The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with all types of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 9, 2025 - 17:15 GMT

FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program

For Immediate Release: May 09, 2025 Today, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced a new, joint innovative research initiative that will serve as a key element in fulfilling U.S. Department of Health and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 9, 2025 - 14:49 GMT

FDA Approves Three Food Colors from Natural Sources

For Immediate Release: May 09, 2025 The U.S. Food and Drug Administration today announced it granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food. The FDA …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 9, 2025 - 11:05 GMT

FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients

For Immediate Release: September 05, 2025 The U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 8, 2025 - 15:15 GMT

FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

For Immediate Release: May 08, 2025 In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 15:32 GMT

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

For Immediate Release: May 06, 2025 Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products …

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Published on April 22, 2025 - 20:41 GMT

HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply

For Immediate Release: April 22, 2025 The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 17, 2025 - 19:08 GMT

FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees

For Immediate Release: April 17, 2025 In keeping with U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s promise to carry out the Department’s work with “radical transparency” and mitigate perceived industry influence and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2025 - 16:55 GMT

FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US

For Immediate Release: December 04, 2025 The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S. for treatment of adults with …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2025 - 11:16 GMT

FDA Conditionally Approves Topical Drug for Cattle for New World Screwworm and Cattle Fever Tick

For Immediate Release: December 04, 2025 Today, the U.S. Food and Drug Administration conditionally approved Exzolt Cattle-CA1 (fluralaner) topical solution for the prevention and treatment of New World screwworm (NWS) larval infestations, and the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 11, 2025 - 21:10 GMT

FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus

For Immediate Release: April 11, 2025 The U.S. Food and Drug Administration today welcomed HHS Secretary Robert F. Kennedy, Jr. to its headquarters in Silver Spring, Maryland, a visit that included remarks to FDA employees, meetings with agency leadership …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 10, 2025 - 19:46 GMT

FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs

For Immediate Release: April 10, 2025 Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 9, 2025 - 09:23 GMT

FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89

For Immediate Release: September 04, 2025 The U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. The agency also released today 89 previously …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2025 - 15:42 GMT

FDA Names Top HHS Lawyer as Chief Counsel

For Immediate Release: August 04, 2025 WASHINGTON — The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced that Sean Keveney has been appointed Chief Counsel at the FDA. Keveney most recently …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2025 - 18:34 GMT

FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors

FDA News Release Medication Can be Given Up to Once Every 2 Months For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2025 - 17:57 GMT

FDA Roundup: March 28, 2025

For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA’s Learning and Education to ADvance and Empower Rare Disease Drug Developers …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2025 - 14:04 GMT

FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis

FDA News Release Today’s Action also Opens the 510(k) Pathway for Other Home Tests for Sexually Transmitted Infections For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration granted marketing authorization to Visby Medical for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 21, 2025 - 20:55 GMT

FDA Roundup: March 21, 2025

For Immediate Release: March 21, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA approved Fabhalta (iptacopan) for the treatment of adults with complement 3 …

Distribution channels: Healthcare & Pharmaceuticals Industry