Although Veklury (remdesivir) is authorized for use in the USA under an Emergency Use Authorization (EUA) for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19, only now has Gilead Sciences (Nasdaq: GILD) applied for formal regulatory approval.
Gilead has submitted a New Drug Application (NDA) to the US Food and Drug Administration for Veklury, marking the final tier of the rolling NDA submission that was initiated on April 8, 2020.
Gilead shares closed yesterday’s trading down 1.2% $68.51.
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