The phase 3 BiPASS trial is evaluating the use of 68Ga-PSMA-PET in combination with MRI for pre-biopsy prostate cancer detection.
Feature|Articles|September 1, 2025
FDA updates in urology: August 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 August 2025.
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Welcome to Urology Times’® monthly FDA update! August ushered in several notable advancements, with a particular focus in prostate cancer. Specifically, key developments included regulatory approval of an artificial intelligence (AI)-based test, acceptance of an application for a new formulation of a prostate-specific membrane antigen (PSMA)-PET imaging agent, and approval of a new formulation of a drug for advanced prostate cancer.
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