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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FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development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The U.S. Food and Drug Administration today issued a draft guidance for...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FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development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The U.S. Food and Drug Administration today issued draft guidance intended to...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...