VIR-5500 is a PSMA-targeted PRO-XTEN dual-masked T-cell engager entering phase 3 development for prostate cancer.
News|Articles|August 4, 2026
FDA updates in urology: July 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 July 2026.
Advertisement
Advertisement
Welcome to Urology Times’® monthly FDA update! This month’s regulatory news featured several practice-changing developments across bladder and prostate cancer, with key approvals in muscle-invasive
Related to this article
Marie-Pier St-Laurent, MD, FRCSC, explains how NeoBLAST combines imaging, TURBT, and ctDNA to identify candidates for bladder-sparing surveillance.
Abraham Morgentaler, MD, reviews evidence showing no association between testosterone therapy and prostate cancer risk and explains the saturation model of androgen action.
Based on these results, the trial protocol has been amended to move enrollment earlier in the course of disease progression.
Mark D. Tyson, II, MD, MPH, reviews emerging bladder-sparing therapies for NMIBC, highlighting cretostimogene data, treatment sequencing, and the need for comparative trials.
An analysis of NRG/RTOG 0815 found Decipher predicted distant metastasis risk and identified patients with greater benefit from short-term ADT.
This FAQ outlines key recommendations and practical takeaways from the AUA/SUO guideline amendment on the diagnosis and treatment of NMIBC.
Peter Clark, MD, discusses key updates to NMIBC guidelines, including revisions to risk stratification, the emerging role of biomarkers, and how to navigate treatment options for BCG-unresponsive disease.
Advertisement
Advertisement