The phase 1 study is intended to characterize the safety, tolerability, and feasibility of intravesical administration of UGN-501.
News|Articles|May 1, 2025
FDA updates in urology: April 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 April 2025.
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Welcome to Urology Times’® monthly FDA update! Last month, key developments included the clearance of a wireless, catheter-free urodynamics system for lower urinary tract dysfunction (LUTD) and a submission for an expanded indication of nogapendekin alfa inbakicept-pmln (NAI, Anktiva) for papillary non–muscle invasive bladder cancer (NMIBC).
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