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Results For "CHMP"

95 News Found

EMA approves Pfizer’s Covid-19 anti-viral candidate
News | December 17, 2021

EMA approves Pfizer’s Covid-19 anti-viral candidate

EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease


Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


European Commission approves Celltrion’s Covid-19 medicine
Drug Approval | November 15, 2021

European Commission approves Celltrion’s Covid-19 medicine

The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week


European Commission approves Ronapreve to treat Covid-19
Drug Approval | November 13, 2021

European Commission approves Ronapreve to treat Covid-19

Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus


Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart
Biotech | February 13, 2021

Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart

The centralized marketing authorization granted by the EC is valid in all EU Member