At a median follow-up of 60.9 months, median EFS was 74.1 months in the pembrolizumab arm and not reached in the placebo arm.
Feature|Articles|December 1, 2025
FDA updates in urology: November 2025
Author(s)Hannah Clarke
Fact checked by: Benjamin P. Saylor, Strategic Content Lead
A recap of the FDA submissions and regulatory decisions in urology from November 2025.
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Welcome to Urology Times’® monthly FDA update! November was a busy month for regulatory news in urology, with several key approvals and several more agents coming down the pike. This month’s notable advances included the removal of the “black box” warning label on hormone replacement therapy, as well as the approval of pembrolizumab (Keytruda) plus enfortumab vedotin-ejfv (Padcev) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
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