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.
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New EU marketing applications from Novimmune, Theratechnologies/TaiMed Biologics and Loxo Oncology have all been granted accelerated assessment by the European Medicines Agency.
Bluebird Bio’s LentiGlobin and Theratechnologies’ Trogarzo are both first of their kind treatments for transfusion-dependent β-thalassemia and HIV respectively.
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.