FDA’s November docket includes at least 11 PDUFA dates, with 10 tied to new products, putting multiple late-stage decisions in the spotlight. The first on deck is PD-1 x VEGF bispecific ivonescimab for non-small cell lung cancer. Summit Therapeutics licensed ivonescimab across the U.S., Europe, Japan and Canada from Akeso in 2022, and the deal was expanded to additional territories in 2024. Akeso retains rights across much of Asia, including China, where ivonescimab was approved in 2024. The docket matters for investors tracking the next wave of FDA determinations tied to bispecific immune-oncology and angiogenesis modulation. Industry attention is heightened further by concurrent combinations, including GSK’s 2025 investment in Summit to pair ivonescimab with its ADC portfolio. With multiple PDUFAs scheduled, the November calendar is likely to shape near-term expectations for revenue and competitive positioning in oncology.