Camurus AB

Four biosimilars sponsors – Biocon Biologics, Gedeon Richter, Mabxience and Zentiva – have each received dual positive opinions from the European Medicines Agency’s Committee for Medicinal Products fo

Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), Vertex Pharmaceuticals’ next generation treatment for cystic fibrosis (CF) is one of six orphan products that the European Medicines Agency backed for

October will see a slowdown in US Food and Drug Administration approval activity, with fewer than half as many user fee goal dates as September. The regulatory shoe is set to drop on two applications

The European Medicines Agency has recommended in favor of pan-EU marketing approval for eight new medicines including Janssen ’s Akeega (niraparib/abiraterone acetate), but says that MSD / Ridgeback