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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 about 19 hours ago
FDA Grants Seventh Approval under the National Priority Voucher Pilot Program
about 19 hours ago
FDA issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1...
FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics
about 24 hours ago
The U.S. Food and Drug Administration today issued a final guidance for...
FDA Expands AI Capabilities and Completes Data Platform Consolidation
3 days ago
FDA announced major steps in its bold initiative to modernize the agency...
FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
3 days ago
FDA announced that it is piloting one-day inspectional assessments, as part of...
FDA Expands Market Access, Authorizes New ENDS Products
4 days ago
FDA today authorized the marketing of four Glas electronic nicotine delivery systems...
FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
8 days ago
FDA is announcing that it issued a “safe to proceed” letter to...
FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia
9 days ago
The U.S. Food and Drug Administration today approved an expanded use for...
FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
9 days ago
FDA is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B...
FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.
10 days ago
FDA announces results from the largest and most rigorous examination ever conducted...
FDA Announces Major Steps to Implement Real-Time Clinical Trials
11 days ago
The U.S. Food and Drug Administration today announced two major steps as...
FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order
15 days ago
On April 18, President Trump issued an Executive Order directing the U.S...
FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
16 days ago
The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the...