Keeping Track Of The US FDA's Final Novel Approvals, CRLs Of 2019
The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.
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US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols
Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.
COVID-19 Vaccines: A Dose Of Caution From Merck
The global COVID-19 pandemic is prompting an unprecedented effort to develop a vaccine in record-breaking time. But there may be pitfalls in letting optimism run too far ahead of the realities of vaccine development.
Coronavirus Vaccine: How Hard Might Development Get? Look At Chikungunya
Epidemiology complicates field efficacy trials, but US FDA advisory committee members regretfully agree that data from non-human primate passive transfer studies is compelling but potentially insufficient for chikungunya vaccines.