FDA’s November docket includes at least 11 PDUFA dates, with 10 tied to new products. The front of the queue is ivonescimab, a PD-1×VEGF bispecific antibody being developed for non-small cell lung cancer. Summit Therapeutics licensed ivonescimab across major regions—including the U.S., Europe, Japan, and Canada—from Akeso in 2022, later expanding the deal to additional territories in 2024. Akeso retains rights in parts of Asia, including China, where it was approved in 2024. The competitive landscape also features large pharma involvement: GSK invested $2 billion in Summit in 2024, pairing ivonescimab with GSK’s antibody-drug conjugate portfolio. The combination deal adds urgency around how regulators view the bispecific’s standalone clinical evidence. With multiple regulatory milestones clustered in a single month, biopharma developers are likely to watch how FDA balances benefit claims across different oncology indications and novel mechanisms.