November 21, 2025
Clinical Updates
Epkinly® (epcoritamab-bysp) – New indication, accelerated approval converted to traditional approval
November 18, 2025 - Genmab announced the FDA approval of Epkinly (epcoritamab-bysp), in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
Drug Approvals
Komzifti™ (ziftomenib) – New drug approval
November 13, 2025 - Kura Oncology and Kyowa Kirin announced the FDA approval of Komzifti (ziftomenib), for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.
Drug Approvals
Poherdy® (pertuzumab-dpzb) – First time interchangeable biosimilar approval
November 13, 2025, the FDA announced the approval of Shangai Henlius’ Poherdy (pertuzumab-dpzb), biosimilar and interchangeable to Roche’s Perjeta (pertuzumab).
Drug Approvals
Redemplo® (plozasiran) – New orphan drug approval
November 18, 2025 - Arrowhead Pharmaceuticals announced the FDA approval of Redemplo (plozasiran), as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
Drug Approvals
Tyruko® (natalizumab-sztn) – First-time biosimilar launch
November 17, 2025 - Sandoz launched Tyruko (natalizumab-sztn), biosimilar to Biogen’s Tysabri (natalizumab).
Drug Safety
Elevidys® (delandistrogene moxeparvovec-rokl) – FDA safety communication
November 14, 2025 - The FDA announced that it was taking action to approve new labeling for Sarepta’s Elevidys (delandistrogene moxeparvovec-rokl), including the addition of a boxed warning and an updated indication section that limits Elevidys' indication to ambulatory patients 4 years of age and older with Duchenne muscular dystrophy (DMD).