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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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Latest posts

Last updated about 19 hours ago

FDA Approves First Drug to Treat Alexander Disease

about 20 hours ago

The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for...

FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats

1 day ago

The U.S. Food and Drug Administration today issued an Emergency Use Authorization...

FDA Seeks Public Input to Advance Development of Botanical Drug Products

1 day ago

The U.S. Food and Drug Administration today announced a request for information...

FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder

7 days ago

The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new...

FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults

8 days ago

The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for...

FDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in Cattle

8 days ago

FDA issues Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the...

FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer

9 days ago

The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS...

FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar

10 days ago

The U.S. Food and Drug Administration today authorized the Libre Duo 10...

FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia

16 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

16 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

17 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

22 days ago

The U.S. Food and Drug Administration today issued an Emergency Use Authorization...