Interim phase 3 data show a 58% reduction in the risk of metastasis or death with the addition of darolutamide to ADT + radiation.
News|Articles|August 1, 2025
FDA updates in urology: July 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 July 2025.
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Welcome to Urology Times’® monthly FDA update! In July, notable advancements were made in the development of a combination regimen for metastatic prostate cancer, an emerging agent in non–muscle invasive bladder cancer (NMIBC), a medication for hypoactive sexual desire disorder (HSDD), and more.
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