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# Gilead Files NDA for Remdesivir
- URL: https://www.fdaweb.com/gilead-files-nda-for-remdesivir/
- Published: 2020-08-10T12:00:00.000Z
- Updated: 2026-09-14T16:24:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147396

Gilead Sciences has submitted an NDA for Veklury (remdesivir), indicated for treating patients with Covid-19\. Remdesivir is currently available in the U.S. under an emergency use authorization for treating hospitalized patients with severe Covid-19\. The submission is based on data from two Phase 3 clinical studies that demonstrated treatment with Veklury led to faster time to recovery compared with placebo and that a five-day or 10-day treatment duration led to similar clinical improvement. Veklury has been approved by the European Union, Japan and other regulatory agencies.