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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 21 hours ago

FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A

about 21 hours ago

The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the...

FDA Launches Expedited IND Pilot, Begins Accepting Applications

3 days ago

The U.S. Food and Drug Administration today announced the final design of...

FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products

14 days ago

The U.S. Food and Drug Administration today announced it is taking action...

FDA Grants Accelerated Approval to a New Breast Cancer Treatment

14 days ago

The U.S. Food and Drug Administration today expanded treatment options for adult...

FDA Approves First Drug to Treat Alexander Disease

15 days 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

15 days 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

15 days 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

21 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

22 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

22 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

23 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

24 days ago

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