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November 19, 2025 16:48 ET | Source: FDA

FDA Pilots Faster Clarifications to Meeting Minutes

Silver Spring, Md., Nov. 19, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal...
November 14, 2025 15:12 ET | Source: FDA

FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury

Silver Spring, Md., Nov. 14, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the...
November 10, 2025 11:31 ET | Source: FDA

HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy

Washington, D.C., Nov. 10, 2025 (GLOBE NEWSWIRE) -- The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health. After...
November 06, 2025 15:07 ET | Source: FDA

FDA Awards Second Batch of National Priority Vouchers

Silver Spring, Md., Nov. 06, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot...
November 05, 2025 14:51 ET | Source: FDA

FDA Warns Companies Over Illegal Marketing of Botox and Related Products

Silver Spring, Md., Nov. 05, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum...