The FDA’s November docket includes at least 11 PDUFA dates, with 10 tied to new products. The first expected decision centers on ivonescimab, a PD-1 x VEGF bispecific antibody intended for non-small cell lung cancer, a program licensed in the U.S. among other regions to Summit Therapeutics from Akeso. The docket timing matters for developers and partners because it affects near-term trial readthrough expectations and commercial planning across a set of upcoming oncology and immunology approvals. The summary also notes Summit’s partnership structure, including GSK’s investment and the intent to combine ivonescimab with the pharma’s ADC portfolio. For biotech investors, a dense PDUFA calendar in November increases catalyst intensity and can shift near-term sentiment across targeted therapeutic franchises that depend on approvals for revenue inflection.