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FDA News

 

Recent news from the US Food and Drug Administration. Click title to see the full article at the FDA website. For the most up-to-date headlines, check out the FDA Newsroom. Press announcements from 2004 to 2009 are available through the FDA Archive.

FDA Recalls: FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This site does not contain a complete list of recalls - search for recalls at the official FDA site.

 

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Special Note: Cyclospora Outbreak 2026

Current information at the FDA website re: the Cyclospora outbreak

 

 

August 2026

August 7, 2026 - FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Multiple Species, Including Sheep, Cattle, Goats, and Swine
August 6, 2026 - FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
August 5, 2026 - FDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 Symptoms

 

July 2026

July 29, 2026 - FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.
July 22, 2026 - FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
July 22, 2026 - FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
July 17, 2026 - FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
July 15, 2026 - FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
July 10, 2026 - FDA Proposes Rule to Modernize Drug Manufacturing Registration
July 1, 2026 - FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease

 

June 2026

June 30, 2026 - FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
June 29, 2026 - FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
June 26, 2026 - FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health
June 17, 2026 - FDA Approves First Single-Dose Generic Treatment for Influenza
June 16, 2026 - FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
June 15, 2026 - FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
June 12, 2026 - FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
June 11, 2026 - FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats
June 9, 2026 - FDA Expands Sunscreen Options for the First Time in 20 Years
June 2, 2026 - FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

 

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