FDA updates in urology: April 2026

Welcome to Urology Times’® monthly FDA update! This month’s regulatory activity features several potentially practice-changing developments across the field, including early movement toward a possible testosterone therapy label expansion, high-impact regulatory progress in perioperative bladder cancer therapy, and FDA advisory committee support for capivasertib (Truqap) in PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). Notably, the FDA’s signals around testosterone replacement therapy could meaningfully reshape care in men’s health, while priority review of enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) in muscle-invasive bladder cancer (MIBC) has the potential to redefine the standard of care if approved.