Gilead’s Comparative Analysis To Bolster Remdesivir Draws Criticism
Gilead says remdesivir improved mortality and clinical recovery in COVID-19 patients, but the findings come from a retrospective analysis, not a traditional clinical trial.
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The FDA emphasized the rigor of its review of the first COVID-19 therapy, which used few expedited pathways on its way to approval after a two-and-a-half-month review. Post-marketing studies will address remaining concerns about dosing and special populations.
Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.
Join us for a quick audio roundup of five useful things to know from Scrip's recent coverage of the global biopharmaceutical industry.