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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Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study
US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.
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
US FDA Complete Response Letter Rates Vary With Sponsor Size
Pink Sheet infographic illustrates benefits of big pharma’s resources and experience.