Gilead submits new drug application to U.S. Food and Drug Administration for Veklury (remdesivir) for the treatment of COVID-19

Gilead

10 August 2020 - Veklury is currently available in the U.S. for the treatment of severe COVID-19 under an Emergency Use Authorisation.

Gilead Sciences announced today that it has submitted a new drug application to the U.S. FDA for Veklury (remdesivir), an investigational antiviral for the treatment of patients with COVID-19. Veklury is currently available in the U.S. under an Emergency Use Authorisation for the treatment of hospitalised patients with severe COVID-19. 

The filing is the final tier of the rolling NDA submission that was initiated on 8 April 2020.

Read Gilead press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier