Hannah Clarke

A recap of the FDA submissions and regulatory decisions in urology from October 2025.

According to the authors, immune-mediated adverse events were manageable and consistent with the known profiles for ICIs.

Avvio Medical plans to submit a de novo application for clearance of the device in early 2026.

Scott B. Sellinger, MD, FACS, discusses the challenges facing urologists, the loss of telehealth flexibility, and why bipartisan action remains urgent.

Merck plans to share these data with regulatory authorities worldwide.

The phase 3 LITESPARK-011 trial has met its primary end point.

Hear from 5 experts as they recap some of the top data from this year's ESMO Congress.

According to the authors, this combination represents a potential new standard of care for this patient population.

The code, J9282, will be effective on January 1, 2026.

Take a look through the top readouts in urologic oncology from ESMO 2025.

Three cycles of chemotherapy was shown to improve patient-reported outcomes vs six cycles, with no detriment to overall survival.

Initial data on pasritamig showed that the agent was well-tolerated and had encouraging preliminary anti-tumor activity in patients with mCRPC.

Data indicates that the DFS improvement was largely driven by the treatment effect in the higher risk population.

The PDUFA target action date for the application is April 7, 2026.

Data from the phase 3 ALBAN trial showed that atezolizumab plus BCG did not improve EFS compared with BCG alone.

The new CPT code will be effective starting on July 1, 2026.

The phase 2 Co-PSMA trial has met its primary end point.

The trial will assess the effect of adding docetaxel to SOC hormone therapy plus apalutamide in mCSPC.

The phase 1 trial is assessing VIR-5500 as both a monotherapy and in combination with ARPIs in prostate cancer.

SBRT demonstrated favorable 4-year biochemical recurrence-free survival with a manageable safety profile.

The study is assessing the safety and tolerability of the CaverSTIM device for ED after surgical removal of the prostate.

The PROSTOX ultra test can predict which patients with localized prostate cancer are at a higher risk of GU toxicity from SBRT.

Data showed that adding niraparib to AAP significantly improved radiographic progression-free survival in this patient population.

Data from the ARC-20 trial show promising efficacy and a manageable safety profile for casdatifan monotherapy.

This announcement follows positive top-line data from a phase 1b/2a clinical trial of EG110A in patients with NDO following a spinal cord injury.

The addition of radiation after surgery improved clinical outcomes while not increasing severe late toxicity in this setting.

The review summarizes results from the OPTIMA II, ATLAS, and ENVISION trials.

Here’s a look back at notable news between July and September 2025.

Take a look back at the notable regulatory decisions in benign urology between July and September.