Spotlight On: Five Key FDA Approvals of 2025

Sevabertinib (Bayer) approved on November 19, 2025, for non-squamous non-small cell lung cancer.1

Itvisma (onasemnogene abeparvovec, Novartis) approved on November 24, 2025, for spinal muscular atrophy (SMA).1

Sibeprenlimab (Otsuka) approved on November 28, 2025, for immunoglobulin A nephropathy (IgAN).1

Ziftomenib (Kura Oncology and Kyowa Kirin) approved on November 30, 2025, for relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutation.1

Breyanzi (lisocabtagene maraleucel, Juno Therapeutics) approved on December 4, 2025, for marginal zone lymphoma.1

Sources:

1. https://checkrare.com/2025-orphan-drugs-pdufa-dates-and-fda-approvals/