Key Takeaways
- Oncology provides the biggest pool of novel candidates with 2025 PDUFA goal dates, with targeted therapies the majority, from kinase inhibitors to an array of antibodies.
- Precision therapies in neurology could boost the neuroscience space after an unusually quiet 2024.
- The peripheral nervous system is the focus of the first neuroscience approval of 2025, Vertex's Journavx (suzetrigine), as well as pending candidates from Seikagaku/Ferring and Axogen.
The novel candidates under US Food and Drug Administration review in oncology and neuroscience, its two biggest pending therapy areas, highlight the deep inroads
The FDA approval of the first tyrosine kinase inhibitor, Novartis’ Gleevec (imatinib), in 2001 began the targeted therapy era in oncology. Almost a quarter century later, the FDA starts the year with eight novel kinase inhibitor drugs under review, mostly for oncology/hematology use, the Pink Sheet US FDA Performance Tracker’s
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