FDA’s November calendar includes at least 11 PDUFA dates, with 10 tied to new products. The schedule spotlights an early marquee decision for PD-1 x VEGF bispecific ivonescimab for non-small cell lung cancer. Summit Therapeutics licensed ivonescimab across multiple regions from Akeso in 2022, expanded the deal in 2024, and Akeso retains rights in much of Asia, including China where the product was approved in 2024. The docket coverage also notes a GSK investment in Summit and a partnership intended to combine ivonescimab with GSK ADCs. For biotech stakeholders, clustered PDUFA catalysts can compress timelines for competitive assessment—especially for immuno-oncology combinations where label scope and future sequencing will depend on the agency’s determinations.