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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 Announces First Participant Selected for TEMPO for Digital Health Devices Pilot

2 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FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food

2 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

7 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

9 days ago

The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid...

FDA Proposes Rule to Modernize Drug Manufacturing Registration

14 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

23 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

24 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

25 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

28 days ago

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

FDA Approves First Single-Dose Generic Treatment for Influenza

about 1 month 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

about 1 month 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

about 1 month ago

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