EMA Confirms Fast-Track EUA-Style Review For Molnupiravir In COVID-19
Rolling Review Is Under Way But Could Take Some Time
The EU regulator says it is taking the emergency use route for molnupiravir because of the worrying rise in coronavirus infections and deaths.
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Coronavirus Notebook: Molnupiravir EU Approval Likely By Year End, Special CHMP Session Due On Comirnaty in 5 to 11-year-olds
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GSK/Vir’s Xevudy Begins EU Review For COVID-19
Things are happening very quickly on the COVID-19 front, with sotrovimab, molnupiravir, Paxlovid and Novaxovid all under EU review for marketing authorization or emergency use, and EMA decisions expected on boosters and the use of vaccines in younger age groups.