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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.
| December 12, 2025 - FDA
Approves Two Oral Therapies to Treat Gonorrhea |
| December 11, 2025 - FDA
Proposes Expanding Sunscreen Active Ingredient List |
| December 9, 2025 - FDA
Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome |
| December 9, 2025 - First
Approval in Commissioner's National Priority Voucher Pilot Program
Strengthens Domestic Antibiotic Manufacturing Capacity |
| December 8, 2025 - FDA
Approves First Cellular Therapy to Treat Patients with Severe Aplastic
Anemia |
| December 5, 2025 - FDA
Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand
Access to Chronic Disease Technologies |
| December 4, 2025 - FDA
Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the
US |
| December 4, 2025 - FDA
Conditionally Approves Topical Drug for Cattle for New World Screwworm
and Cattle Fever Tick |
| December 3, 2025 - FDA
Announces Leadership Appointments at Center for Drug Evaluation and
Research |
| December 3, 2025 - FDA
Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity |
| December 2, 2025 - FDA
Seizes 7-OH Opioids to Protect American Consumers |
| December 2, 2025 - FDA
Releases Draft Guidance on Reducing Testing on Non-Human Primates
for Monoclonal Antibodies |
| December 1, 2025 - FDA
Expands Artificial Intelligence Capabilities with Agentic AI Deployment |
See the current
MedSun newsletter at the FDA website for Recalls and Safety Alerts,
Highlighted Reports, and Links to FDA/CDRH Databases and Other Information
Sources.
- January
2025
- February 2025
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