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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 17 hours ago
FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
about 17 hours ago
The U.S. Food and Drug Administration today granted accelerated approval to Tudriqev...
FDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 Symptoms
1 day ago
The FDA approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type...
FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.
9 days ago
FDA today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first...
FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
16 days ago
The U.S. Food and Drug Administration today announced the first manufacturer selected...
FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
16 days ago
The U.S. Food and Drug Administration today announced two actions targeting petroleum-based...
FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
21 days ago
The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral...
FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
23 days ago
The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid...
FDA Proposes Rule to Modernize Drug Manufacturing Registration
28 days ago
The U.S. Food and Drug Administration today issued a proposed rule that...
FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
about 1 month ago
The U.S. Food and Drug Administration today issued a supplemental approval for...
FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
about 1 month ago
The U.S. Food and Drug Administration today approved TREGZI, the first regulatory...
FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
about 1 month ago
FDA announces the selection of seven companies to participate in the FDA...
FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health
about 1 month ago
The U.S. Food and Drug Administration today issued a proposed rule that...