enGene expects to initiate a BLA submission by the end of 2026.
Feature|Articles|October 1, 2025
FDA updates in urology: September 2025
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 September 2025.
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Welcome to Urology Times’® monthly FDA update! This month’s notable regulatory decisions span the gamut of urologic care—including new approvals in bladder cancer, solid tumors, and benign conditions.
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