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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.
| May 29, 2026 - FDA
Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer
Drugs |
| May 22, 2026 - FDA
Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection |
| May 20, 2026 - FDA
Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday
Products |
| May 12, 2026 - FDA
Finalizes Food Chemical Safety Post-Market Assessment Program, Launches
Reassessment of BHT, ADA |
| May 11, 2026 - FDA
Advances Drug Repurposing to Address Unmet Medical Needs |
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May 8, 2026 - FDA
Grants Seventh Approval under the National Priority Voucher Pilot
Program
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| May 8, 2026 - FDA
Issues Guidance to Improve Collection of Pregnancy Safety Data for
Drugs and Biologics |
| May 6, 2026 - FDA
Expands AI Capabilities and Completes Data Platform Consolidation |
| May 6, 2026 - FDA
Launches One-Day Inspectional Assessments to Strengthen and Expand
Oversight |
| May 5, 2026 - FDA
Expands Market Access, Authorizes New ENDS Products |
| May 1, 2026 - FDA
Permits Expanded Access for Investigational Pancreatic Cancer Drug |
| 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 |
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