Keeping Track: FDA Approves Novel HIV Treatment, New Dosing Regimen For Opdivo; Another Rare Pediatric Disease Designation For Prometic
The latest drug development news and highlights from our US FDA Performance Tracker.
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Shire’s Prucalopride Brings Real-World CV Safety Data To US FDA Panel, But Will It Be Enough?
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US FDA Reviews IBS-C Candidates Both New (Tenapanor) And Old (Tegaserod)
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TaiMed's Trogarzo Is US FDA's First HIV/AIDS Breakthrough Approval
Unusual review of ibalizumab-uiyk marks other HIV firsts too: first monoclonal antibody and first new mechanism of action in 10 years. Company considered several routes of administration, and the Phase III trial was actually smaller than the Phase II study.