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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 1 day ago
FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia
2 days ago
The U.S. Food and Drug Administration today issued an accelerated approval for...
FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device
2 days ago
The U.S. Food and Drug Administration today authorized the Aletta, the first...
FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices
3 days ago
The U.S. Food and Drug Administration today issued a discussion paper on...
FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies
8 days ago
The U.S. Food and Drug Administration today issued an Emergency Use Authorization...
FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Multiple Species, Including Sheep, Cattle, Goats, and Swine
14 days ago
FDA today issued an Emergency Use Authorization (EUA) for CLiK Extra (dicyclanil...
FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
15 days 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
16 days 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.
23 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
30 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FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
about 1 month 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
about 1 month 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
about 1 month ago
The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid...