enGene expects to initiate a BLA submission by the end of 2026.
Feature|Articles|July 1, 2025
FDA updates in urology: June 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 June 2025.
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Welcome to Urology Times’® monthly FDA update! June was a busy month for urological regulatory news, featuring new approvals for prostate cancer, bladder cancer, benign prostatic hyperplasia (BPH), and incontinence. Additionally, notable advancements were made in the development of an oral antibiotic for uncomplicated gonorrhea, a theranostic radiopharmaceutical in prostate cancer, and a gene-based immunotherapy in bladder cancer.
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