Expected FDA decision dates for new drugs and major new uses. The FDA does not publish these dates; each comes from the company's own announcement, which is linked beside it. Dates are expected, not guaranteed, and we update each entry after the decision.
November 2026
Nov 14Expected
Ivonescimab (with chemotherapy) New drug
EGFR-mutated non-squamous non-small cell lung cancer after EGFR TKI therapy, in combination with platinum-doublet chemotherapy (HARMONi trial)
Summit Therapeutics · BLA · PDUFA goal date: Nov 14, 2026
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For healthcare professionals. Expected dates come from company announcements and can change; the FDA may act earlier or later. Not medical advice.
What a PDUFA date is
Under the Prescription Drug User Fee Act, the FDA sets a goal date for acting on each application: about 10 months after filing for a standard review and 6 months for a priority review. Companies usually announce the date when the FDA accepts the application. The FDA can act early, extend the date by 3 months after a major amendment, approve, or send a complete response letter explaining why it cannot approve yet.
How we keep this calendar
Every date links to the company's announcement it comes from, with the announcement's date. After the goal date we check FDA's records and update the entry with the outcome and its FDA source. Approved new drugs get their own page on our approvals list.
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