Keeping Track: Four Novel Agents Clear US FDA, Including Evrysdi, Blenrep

The US Food and Drug Administration’s approvals of Genentech, Inc.’s Evrysdi (risdiplam) and MorphoSys AG’s Monjuvi (tafasitamab-cxix) ahead of their user goal dates helped bring the past week’s novel approval count to four – and the Center for Drug Evaluation and Research’s new molecular entity and novel biologic count for 2020 to 33.

Monjuvi’s approval was followed a few days later by the clearance of another biologic for hematologic oncology, GlaxoSmithKline plc’s Blenrep (belantamab mafodotin-blmf)