The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
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
Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune
Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)
Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)
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
Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus
A final decision regarding the approval of Ronapreve is expected from the European Commission shortly
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency
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