Tags : US FDA’s

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as

Shots: The US FDA has issued a EUA for casirivimab (1,200mg) + imdevimab (1,200mg) administered together for mild to mod. COVID-19 in adults and pediatric patients aged ≥12yrs. weighing at least 40kg [~88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 The EUA […]Read More

Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373

Shots: The US FDA has granted FT designation to NVX-CoV2373 which is currently in late-phase clinical development. Novavax expects to initiate pivotal P-III study in the US & Mexico by the end of Nov’2020 The company’s ongoing P-lll trial in the UK to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 is expected to be […]Read More