Tags : sotrovimab

Regulatory

GSK and Vir Receive the US FDA’s EUA for Sotrovimab

Shots: The US FDA has granted EUA for sotrovimab for mild to mod. COVID-19 patients aged ≥12yrs. who are at high risk for progression to severe COVID-19 including hospitalization for >24hrs. or death The EUA is based on an interim analysis from the P-III COMET-ICE trial that demonstrated an 85% reduction in hospitalization or death. […]Read More

Regulatory

GSK and Vir Report Initiation of EMA Rolling Review of

Shots: The rolling review will assess sotrovimab in adults and adolescents (aged 12yrs.) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The rolling review will support a formal MAA EMA’s CHMP will review the data and the decision to start the rolling review is based […]Read More