Speedy Approval Of Gilead’s Veklury Sets Stage For Pediatric Expansion, Dosing Refinement
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
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Keeping Track: Chiesi Breathes Easier With Bronchitol Approval; Submissions Aplenty From GSK, Pfizer, AZ, AbbVie
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.
The FDA has almost 30 decision dates coming up before New Year’s Eve, including nearly a dozen novel agents.