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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European postmarketing epidemiological study results ‘reasonably exclude’ a greater than three-fold increased risk of major adverse cardiovascular events with the constipation drug but, due to potential bias, cannot definitively exclude a possibly unacceptable level of risk, agency says.
Ardelyx touts tenapanor's novel mechanism, favorable safety profile; advisory committee announcement reveals US Worldmeds’ bid to revive Novartis’ withdrawn Zelnorm.
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.