DATA GRAPHICS | Data Byte
FDA approved five NMEs in November
Two biotechs received their first product approvals in a month that also delivered the first pertuzumab biosimilar
December 4, 2025 10:27 PM UTC
FDA approved five new molecular entities (NMEs) in November, including the first approvals for Kura Oncology Inc. (NASDAQ:KURA) and Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR).
FDA also approved the first interchangable biosimilar to breast cancer drug Perjeta pertuzumab. Shanghai Henlius Biotech Inc. (HKEX:2696) developed and registered Poherdy pertuzumab-dpzb; Organon & Co. (NYSE:OGN) will market it under a 2022 deal. Organon did not announce a launch date or price for Poherdy...