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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.
| April 30, 2026 - FDA
Approves First Non-Antipsychotic Drug to Treat Agitation Associated
with Dementia |
| April 30, 2026 - FDA
Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B
Bulks List |
| April 29, 2026 - FDA
Releases Results from Largest-Ever Testing of Infant Formula in the
U.S. |
| April 28, 2026 - FDA
Announces Major Steps to Implement Real-Time Clinical Trials |
| April 24, 2026 - FDA
Accelerates Action on Treatments for Serious Mental Illness Following
Executive Order |
| April 23, 2026 - FDA
Approves First-Ever Gene Therapy for Treatment of Genetic Hearing
Loss Under National Priority Voucher Program |
| April 23, 2026 - CMS
and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access
to Life-Changing Medical Devices |
| April 20, 2026 - FDA
Achieves Year 1 Goals in Reducing Animal Testing in Drug Development |
| April 16, 2026 - FDA
Takes Step Forward on Testosterone Therapy for Men |
| April 14, 2026 - FDA
Issues Draft Guidance on Genome Editing Safety Standards to Advance
Gene Therapy Development |
| April 13, 2026 - FDA
Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial
Results |
| April 1, 2026 - FDA
Approves First New Molecular Entity Under National Priority Voucher
Program |
| March 26, 2026 - FDA
Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency
Type I |
| March 25, 2026 - FDA
Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome |
| March 20, 2026 - FDA
Schedules Public Meeting on the Commissioner’s National Priority
Voucher Pilot Program |
| March 19, 2026 - FDA
Approves Fourth Product Under National Priority Voucher Program, Higher
Dose Semaglutide |
| March 18, 2026 - FDA
Releases Draft Guidance on Alternatives to Animal Testing in Drug
Development |
| March 11, 2026 - FDA
Launches New Adverse Event Look-Up Tool |
| March 10, 2026 - FDA
Approves First Treatment for Patients with Cerebral Folate Transport
Deficiency |
| March 9, 2026 - FDA
Takes Further Steps to Streamline Biosimilar Development and Make
Medicines More Affordable |
| March 6, 2026 - FDA
Holds Meeting with States on Importation of Lower Cost Drugs |
| March 5, 2026 - FDA
Grants Third Approval Under the National Priority Voucher Program |
| March 5, 2026 - FDA
to Address Unused Opioids in American Homes |
| March 3, 2026 - FDA
Warns 30 Telehealth Companies Against Illegal Marketing of Compounded
GLP-1s |
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