The approval is supported by data from the phase 3 LITESPARK-011 trial.
News|Articles|June 3, 2026
FDA updates in urology: May 2026
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 May 2026.
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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.
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