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Latest posts
Last updated about 3 hours ago
FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
about 4 hours ago
Since publishing roadmap last April, agency has successfully launched several key initiatives...
FDA Takes Step Forward on Testosterone Therapy for Men
4 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FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
6 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The U.S. Food and Drug Administration today issued a draft guidance for...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
7 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
19 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
25 days ago
The U.S. Food and Drug Administration today approved Kresladi (marnetegragene autotemcel), the...
FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome
26 days ago
The U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) to treat...
FDA Schedules Public Meeting on the Commissioner’s National Priority Voucher Pilot Program
about 1 month ago
As part of the U.S. Food and Drug Administration’s continuous quality improvement...
FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide
about 1 month ago
The U.S. Food and Drug Administration today approved a new higher dose...
FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development
about 1 month ago
The U.S. Food and Drug Administration today issued draft guidance intended to...
FDA Launches New Adverse Event Look-Up Tool
about 1 month ago
FDA launched a new unified platform for analyzing adverse event reports. This...
FDA Approves First Treatment for Patients with Cerebral Folate Transport Deficiency
about 1 month ago
The U.S. Food and Drug Administration today approved expanded use of Wellcovorin...