Bladder symptoms during IVF often reflect hormonal and pelvic floor changes, not infection, according to Aleece Fosnight, MSPAS, PA-C.
Feature|Articles|October 1, 2025
FDA updates in urology: September 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 September 2025.
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Welcome to Urology Times’® monthly FDA update! This month’s notable regulatory decisions span the gamut of urologic care—including new approvals in bladder cancer, solid tumors, and benign conditions.
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Michael S. Cookson, MD, MMHC, FACS, discusses how Anktiva’s expanded FDA approval may broaden bladder-preserving treatment options for BCG-unresponsive papillary-only NMIBC.
This approval expands the perioperative use of pembrolizumab plus enfortumab vedotin to all patients with MIBC, regardless of cisplatin eligibility.
The agency issued a PDUFA target action date of June 14, 2027.
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.
Vignesh Packiam, MD, discusses strategies to manage intravesical therapy toxicity in NMIBC, improve treatment tolerability, and preserve bladder function.
Sandip M. Prasad, MD, MPhil, discusses the safety profile of mitomycin intravesical solution, including common adverse events and patient counseling during chemoablation for NMIBC.
Sandip M. Prasad, MD, MPhil, discusses 3-year ENVISION trial data showing durable responses with mitomycin intravesical solution for recurrent LG-IR-NMIBC.
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