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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.

 

2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026

 

 

Special Note: Cyclospora Outbreak 2026

Current information at the FDA website re: the Cyclospora outbreak

 

 

September 2026

September 17, 2026 - FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
September 15, 2026 - FDA Launches Expedited IND Pilot, Begins Accepting Applications
September 4, 2026 - FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
September 4, 2026 - FDA Grants Accelerated Approval to a New Breast Cancer Treatment
September 3, 2026 - FDA Approves First Drug to Treat Alexander Disease
September 3, 2026 - FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats
September 3, 2026 - FDA Seeks Public Input to Advance Development of Botanical Drug Products

 

August 2026

August 28, 2026 - FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder
August 27, 2026 - FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults
August 27, 2026 - FDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in Cattle
August 26, 2026 - FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
August 25, 2026 - FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
August 19, 2026 - FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia
August 19, 2026 - FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device
August 18, 2026 - FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices
August 13, 2026 - FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies
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

 

2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026

 

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