Aspaveli receives positive CHMP opinion for treatment of paroxysmal nocturnal haemoglobinuria – SOBI + Apellis Pharma

Swedish Orphan Biovitrum AB (publ) (Sobi) and Apellis Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least […]

EMA gives green light for six new medicines

A total of 67 new medicines have been approved by the European Medicines Agency (EMA) in 2021. This includes six new products backed by the watchdog’s key advisory body, the Committee on Human Medicinal Products (CHMP). The newly approved products are: Trodelvy (sacituzumab govitecan) for the treatment of unresectable or metastatic triple-negative breast cancer. Rybrevant (amivantamab), conditionally approved for the treatment of […]