Latest News and Press Releases

Want to stay updated on the latest news?

Sign into Reader Account Create Reader Account

May 06, 2026 15:42 ET | Source: FDA

FDA Expands AI Capabilities and Completes Data Platform Consolidation

White Oak, Md., May 06, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a...
May 06, 2026 15:33 ET | Source: FDA

FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

White Oak, Md., May 06, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make...
May 05, 2026 16:27 ET | Source: FDA

FDA Expands Market Access, Authorizes New ENDS Products

White Oak, Md., May 05, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the...
April 29, 2026 12:19 ET | Source: FDA

FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.

White Oak, Md., April 29, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced results from the largest and most rigorous examination ever conducted focused on chemical...
April 28, 2026 13:49 ET | Source: FDA

FDA Announces Major Steps to Implement Real-Time Clinical Trials

White Oak, Md., April 28, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical...
April 24, 2026 15:58 ET | Source: FDA

FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order

White Oak, Md., April 24, 2026 (GLOBE NEWSWIRE) -- President Trump on April 18 issued an Executive Order directing the U.S. Department of Health and Human Services to accelerate access to treatments...
April 23, 2026 22:04 ET | Source: FDA

FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program

White Oak, Md., April 24, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV)...
February 12, 2026 12:57 ET | Source: FDA

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

White Oak, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic...
February 12, 2026 12:38 ET | Source: FDA

FDA Approves Labeling Changes to Menopausal Hormone Therapy Products

White Oak, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone...
January 11, 2026 21:18 ET | Source: FDA

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

White Oak, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry,...