News|Articles|February 2, 2026

FDA updates in urology: January 2026

Author(s)Hannah Clarke

A recap of the FDA submissions and regulatory decisions in urology from January 2026.

Welcome to Urology Times’® monthly FDA update! The year began with a couple of notable regulatory updates, including fast track designation for a novel platform that can deliver enzalutamide (Xtandi) directly into prostate tissue as well as FDA clearance for a new kidney stone device.