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Food and Drug Administration--Press Releases
Get the latest updates from Food and Drug Administration--Press Releases directly as they happen.
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Last updated 6 days ago
FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy
6 days ago
The U.S. Food and Drug Administration today approved Itvisma (onasemnogene abeparvovec-brve) for...
FDA Pilots Faster Clarifications to Meeting Minutes
11 days ago
The U.S. Food and Drug Administration today announced a pilot program designed...
FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
16 days ago
The U.S. Food and Drug Administration today announced it is taking action...
Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research
19 days ago
The U.S. Department of Health and Human Services (HHS) and the U.S...
HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
20 days ago
The U.S. Department of Health and Human Services (HHS) today announced historic...
HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
20 days ago
The U.S. Department of Health and Human Services (HHS) today announced historic...
HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
20 days ago
The U.S. Department of Health and Human Services (HHS) today announced historic...
FDA Awards Second Batch of National Priority Vouchers
24 days ago
The U.S. Food and Drug Administration today announced six additional awardees under...
FDA Warns Companies Over Illegal Marketing of Botox and Related Products
25 days ago
The U.S. Food and Drug Administration issued 18 warning letters to owners...
FDA Acts to Protect Children from Unapproved Fluoride Drug Products
about 1 month ago
The U.S. Food and Drug Administration today announced actions to restrict the...
FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs
about 1 month ago
The U.S. Food and Drug Administration (FDA) today announced significant action to...
FDA Issues Emergency Use Authorization for New World Screwworm Drug for Dogs
about 1 month ago
FDA issued an Emergency Use Authorization (EUA) concluding that based on the...