Long-term QUILT-3.032 findings show durable responses with Anktiva plus BCG in BCG-unresponsive NMIBC, with an estimated 84.2% cystectomy-free survival at 3 years.
News|Articles|November 3, 2025
FDA updates in urology: October 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 October 2025.
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Welcome to Urology Times’® monthly FDA update! This month’s notable regulatory decisions reflected the innovation coming down the pike, with a focus on priority reviews, fast track designations, and breakthrough device designations. From advancing next-generation therapeutics for bladder and prostate cancer to progressing minimally invasive technologies for stone disease, these updates underscore the ongoing progress across the spectrum of urologic care.
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