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The FDA has issued an Emergency Use Authorization (EUA) for Regeneron's investigational monoclonal antibodies casirivimab (REGN10933) and imdevimab (REGN10987) to be administered together by IV infusion for treatment of mild to moderate COVID-19 in adults and pediatric patients (≥12 years old and weigh ≥40 kg) who are at high risk of progressing to severe COVID-19 and/or hospitalization (see Table 1).1 Bamlanivimab (LY-CoV555; Lilly), another monoclonal antibody, received an EUA for the same indication on November 9, 2020.2Monoclonal antibodies may be associated with worse clinical outcomes when administered to... Continue reading More from Issue 1614Advance ReleaseADVANCERELEASEFDA Authorizes Moderna COVID-19 Vaccine On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech mRNA-based vaccine received an FDA EUA for the same indication in persons ≥16 years old on December 11, 2020.1CLINICAL STUDY —... Continue reading TweetsTweets by @MedicalLetter<<< Thank you for your visit >>>
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