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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 9 days ago

FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease

9 days 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

10 days 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

11 days 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

14 days ago

The U.S. Food and Drug Administration today issued a proposed rule that...

FDA Approves First Single-Dose Generic Treatment for Influenza

23 days ago

The U.S. Food and Drug Administration today approved the first generic of...

FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

24 days ago

The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC)...

FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes

25 days ago

On June 12, 2026, the U.S. Food and Drug Administration granted accelerated...

FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

28 days ago

The U.S. Food and Drug Administration today cleared for marketing the first...

FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats

29 days ago

FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets...

FDA Expands Sunscreen Options for the First Time in 20 Years

about 1 month ago

Today, the U.S. Food and Drug Administration added bemotrizinol to the list...

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

about 1 month ago

The U.S. Food and Drug Administration (FDA) today issued draft guidance to...

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

about 1 month ago

The U.S. Food and Drug Administration today issued a draft guidance to...