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Latest posts
Last updated about 6 hours ago
FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.
about 7 hours ago
FDA announces results from the largest and most rigorous examination ever conducted...
FDA Announces Major Steps to Implement Real-Time Clinical Trials
1 day ago
The U.S. Food and Drug Administration today announced two major steps as...
FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order
5 days ago
On April 18, President Trump issued an Executive Order directing the U.S...
FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
6 days ago
The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the...
CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices
6 days ago
CMS and FDA announce the Regulatory Alignment for Predictable and Immediate Device...
FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
9 days ago
Since publishing roadmap last April, agency has successfully launched several key initiatives...
FDA Takes Step Forward on Testosterone Therapy for Men
13 days ago
FDA is taking an initial step to advance treatment options for men’s...
FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
15 days ago
The U.S. Food and Drug Administration today issued a draft guidance for...
FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
16 days ago
The U.S. Food and Drug Administration has reminded more than 2,200 medical...
FDA Approves First New Molecular Entity Under National Priority Voucher Program
28 days ago
The U.S. Food and Drug Administration today approved Foundayo (orforglipron) marking the...
FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I
about 1 month ago
The U.S. Food and Drug Administration today approved Kresladi (marnetegragene autotemcel), the...
FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome
about 1 month ago
The U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) to treat...