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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.
| September 30, 2026 - FDA
Launches Nationwide Effort to Expand Scientific Expertise and Consumer
Voices to Advisory Committees |
| September 29, 2026 - FDA
Investigation Leads to Charges Against Two Indian Nationals Involved
in Transnational Counterfeit Drug Distribution Scheme |
| September 28, 2026 - FDA
Approves First Treatment for MCT8 Deficiency |
| September 28, 2026 - FDA
intends to evaluate changes to the PMTA regulatory framework |
| September 23, 2026 - Federal
Court Enters Consent Decree Against Gold Star Distribution, Inc. Following
Persistent Insanitary Warehouse Conditions |
| September 21, 2026 - FDA
Updates Regulations to Advance Innovative Alternatives to Animal Testing
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| 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 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 |
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