Gilead’s Veklury Approval Shows US FDA’s Existing Regulatory Tools Are Up To The COVID-19 Challenge
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.
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Unlike the current EUA fact sheet, Spikevax’s approved labeling does not state that the vaccine may pose an increased risk of myocarditis ‘relative to other authorized or approved mRNA COVID-19 vaccines.’ Approval brings Moderna a priority review voucher, as did Comirnaty’s approval for BLA sponsor BioNTech.
Keeping Track: Immunocore Wins Nod For First T-Cell Receptor Therapeutic; Veklury And Nucala Expand Settings Of Use; Merck & Co. Strikes Out In Chronic Cough
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.