EU Approves Gilead’s Remdesivir For COVID-19 In Record Time
Despite The Controversy, Blockbuster Status Is Predicted
The EU has granted conditional marketing approval to Gilead’s drug, which has the brand name Veklury. It will cost about €2,000 per treatment.
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EU Accelerated Assessment Tracker
Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
Second COVID-19 Vaccine Undergoes ‘Rolling Review’ By EMA
The European Medicines Agency is fast-tracking its review of the vaccine that BioNTech and Pfizer are developing and testing in Phase III trials.
Rasi To Ombudsman: No Risk Of Bias In EMA’s COVID-19 Drug Evaluations
European Medicines Agency chief Guido Rasi has responded to questions by the European Ombudsman about its COVID-19 Pandemic Task Force.