Remdesivir heads for FDA review as Gilead continues to build manufacturing pipeline 

As Gilead continues to expand its manufacturing capabilities for Veklury, the company has moved a step closer to gaining full approval of the therapy in the U.S. for COVID-19. The company announced its NDA submission for the antiviral on a day that saw shares of Omeros rise 51% on the heels of positive COVID-19-associated acute respiratory distress syndrome data and IAVI and Wellcome issue a call to improve global access to mAbs for COVID-19 and more.    

Veklury remdesivir has been available in the U.S. under an EUA since May 1 for patients hospitalized with severe COVID-19; a week later Japan’s  Ministry of Health, Labour and Welfare approved the  Gilead Sciences Inc. (NASDAQ:GILD) drug via an exceptional approval pathway due to the pandemic. The European Commission approved the therapy on July 3...