FDA updates in urology: November 2025

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.