FDA updates in urology: May 2026

Welcome to Urology Times’® monthly FDA update! This month’s regulatory activity includes 2 notable approvals in the bladder cancer space—circulating tumor DNA (ctDNA)-guided atezolizumab (Tecentriq) as adjuvant therapy for muscle-invasive bladder cancer (MIBC) and durvalumab for BCG-naïve, high-risk non–muscle invasive bladder cancer (NMIBC). The month of May also welcomed FDA submissions for the Edison Histotripsy System for the destruction of kidney tumors and for nogapendekin alfa inbakicept-pmln (Anktiva) in papillary NMIBC.