Pink Sheet
>>Product Reviews
>>Approvals

Gilead’s Veklury Approval Shows US FDA’s Existing Regulatory Tools Are Up To The COVID-19 Challenge

23 Oct 2020

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.

Gilead_USA — Gilead's remdesivir is first COVID-19 therapeutic to be approved by FDA

One of many striking things about the US Food and Drug Administration’s 22 October approval of the first COVID-19 therapeutic is how routine the agency action is despite the unusual pressures of the times.

Gilead Sciences, Inc.’s Veklury (remdesivir) received regular approval with an NDA based on three Phase III trials with hard...