FDA to Review Eleven New Drugs in November 2026

The FDA has set eleven action dates for next month, including ten reviews for new pharmaceutical products.

Updated on Oct. 31, 2026 in Biotech

Isometric editorial illustration of eleven empty, sterile glass vials arranged in a grid, representing the pharmaceutical review pipeline. — The FDA will conduct eleven PDUFA reviews in November 2026, marking a significant milestone for pharmaceutical developers awaiting regulatory approval. AI Illustration. Upload story photo >

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In November 2026, the FDA is set to complete 11 Prescription Drug User Fee Act (PDUFA) reviews. Ten of these scheduled dates involve the assessment of new pharmaceutical products.

Why it matters

These scheduled reviews are critical milestones for drug developers awaiting regulatory approval to bring new treatments to the U.S. market. The pipeline of new products reflects the ongoing effort to expand therapeutic options for patients.

The upcoming cycle includes 11 PDUFA action dates, with 10 of those reviews dedicated to new pharmaceutical products. Ivonescimab, which was licensed from Akeso and approved in China in 2024, is the first drug slated for review in this November timeframe.

The players

FDA

This federal agency is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs.

Summit Therapeutics

This clinical-stage biopharmaceutical company focuses on discovering, developing, and commercializing new therapies for patients with serious illnesses.

GSK

This multinational pharmaceutical and biotechnology company operates as a major global investor in medical research and drug development.

Akeso

This biopharmaceutical company specializes in the research and development of antibody-based drugs, including the development of ivonescimab.

The details

Summit Therapeutics is a key player in this cycle, having expanded its licensing deal for ivonescimab in 2024 after initial acquisition in 2022. The company also secured a $2 billion investment from GSK in 2026 to advance development, including partnerships to combine the drug with ADCs.

Summit Therapeutics licensed ivonescimab from Akeso in 2022.
Ivonescimab received approval in China in 2024.
Summit Therapeutics expanded its licensing deal in 2024.
GSK invested $2 billion in Summit Therapeutics in 2026.
The FDA scheduled 11 PDUFA action dates in November 2026.

The Tech Race

These upcoming reviews demonstrate the continued reliance on the Prescription Drug User Fee Act to manage the rigorous pace of pharmaceutical innovation. This milestone highlights the industry push toward complex antibody-drug conjugates as a replacement for traditional legacy therapies.

Patients and healthcare providers awaiting new treatment options will see the results of these reviews throughout November. The outcomes will determine when and how these new pharmaceutical products become available for prescription in the United States.

The takeaway

The November 2026 review schedule highlights the significant investment from major corporations like GSK into specialized biopharmaceutical firms. Readers should monitor these regulatory decisions as they serve as indicators for the next generation of available medical treatments.