FDA updates certain COVID-19 monoclonal antibody authorizations

The Food and Drug Administration Friday updated its emergency use authorizations for two intravenous infusion therapies for outpatients at risk for progressing to severe COVID-19 disease. Specifically, it updated the patient selection criteria and safety summary for the monoclonal antibodies bamlanivimab and etesevimab administered together, and the patient selection criteria for the monoclonal antibodies casirivimab with imdevimab (REGEN-CON) administered together. For details on the changes, see the FDA fact sheets for bamlanivimab and etesevimab and REGEN-COV.