Second Chance For Roche’s Polivy At CHMP
It's decision time again at the European Medicines Agency and Roche's Polivy and AstraZeneca's Qternmet are among the products up for an opinion on whether they should be approved in the EU.
You may also be interested in...
Just two products are being assessed under the EMA's fast-track mechanism now that the marketing application for Roche's Polivy has reverted to standard review.
Seven new drugs have this week moved closer to gaining EU approval following positive recommendations from the European Medicines Agency, but Emmaus’ glutamine product has fared less well and the company is considering another route for getting the drug to sickle cell disease patients in Europe
Vertex’s triple combination regimen for cystic fibrosis and two Ebola vaccines from Janssen are among the latest potential new products being considered for accelerated assessment by the European Medicines Agency.