11 New Drug Reviews to Reach FDA Deadline in November
The FDA has scheduled 11 final regulatory reviews for November 2026, including 10 assessments of new pharmaceutical products.
Updated on Oct. 31, 2026 in Biotech
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The FDA has finalized its schedule for November 2026, setting 11 Prescription Drug User Fee Act (PDUFA) action dates. Ten of these scheduled reviews pertain to new pharmaceutical products.
Why it matters
These PDUFA dates mark the final regulatory milestones for a cohort of potential new therapies, signaling the next phase of market entries for various pharmaceutical companies.
The FDA tracks 11 action dates in November 2026 for new drug applications, serving as the regulatory deadline for final approval decisions. These reviews follow the standard PDUFA framework, which governs the timeline for the agency to evaluate safety and efficacy data.
The players
FDA
The U.S. federal agency responsible for regulating food and drug safety through clinical trial oversight and market authorization.
Summit Therapeutics
A biotechnology company focused on the development of new cancer therapies through strategic licensing and clinical partnerships.
GSK
A multinational pharmaceutical firm with an extensive portfolio in vaccines and specialty medicines that recently invested $2 billion into Summit Therapeutics.
Akeso
A biopharmaceutical company specializing in the research and development of protein drugs and antibody therapies.
The details
The FDA process utilizes PDUFA dates to manage the evaluation of submitted drug applications, ensuring a structured timeline for review and decision-making. Among the scheduled reviews is ivonescimab, a drug Summit Therapeutics licensed from Akeso in 2022 and expanded in 2024. Ivonescimab, which received approval in China in 2024, is currently being developed by Summit Therapeutics in partnership with GSK to potentially combine the drug with ADCs—antibody-drug conjugates, a class of biopharmaceutical drugs designed as a targeted therapy for treating cancer.
Timeline
2022: Summit Therapeutics licensed ivonescimab from Akeso.
2024: Summit Therapeutics expanded its licensing deal and China approved ivonescimab.
2026: GSK invested $2 billion in Summit Therapeutics.
November 2026: The FDA scheduled 11 PDUFA action dates.
The Tech Race
The upcoming November 2026 reviews underscore the intensifying competition to bring novel oncology treatments through the FDA's regulatory pipeline. This phase follows recent capital infusions, such as the $2 billion GSK investment, aimed at accelerating the commercialization of therapies like ivonescimab.
The outcomes of these 11 FDA reviews will determine which new pharmaceutical treatments become available for medical use in the United States. Patients and providers should watch for individual decision announcements throughout November 2026 to understand new therapeutic options.
The takeaway
The November 2026 PDUFA schedule serves as the primary indicator for the commercial viability of several high-profile drug candidates. Interested parties should monitor upcoming FDA announcement logs for the final status of these 11 drug applications.
Further reading
For broader trends in drug development and approval, explore the Biotech section.
Source note: This article includes information reported by BioCentury.
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