The phase 1 study is intended to characterize the safety, tolerability, and feasibility of intravesical administration of UGN-501.
News|Articles|September 1, 2026
FDA updates in urology: August 2026
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 2026.
Advertisement
Advertisement
Welcome to Urology Times’® monthly FDA update! This month’s regulatory news featured new device and drug developments across benign and oncologic urology care, including 2 advances that build on existing therapeutic platforms.
Related to this article
Paras H. Shah, MD, recaps data on emerging agents in high-risk NMIBC from the 2026 AUA North Central Section Meeting.
Five-year follow-up data show durable responses with UGN-101 in patients with low-grade upper tract urothelial carcinoma who achieved an initial complete response.
The final analysis confirmed PFS and response benefits in previously treated advanced clear cell renal cell carcinoma, but the OS difference did not cross the prespecified significance boundary.
Topline results are expected in November 2026 ahead of a planned sBLA submission.
Brian I. Rini, MD, FASCO, explains why LITESPARK-012’s negative triplet results still offer lessons on drug delivery and building on first-line RCC doublets.
In a POTOMAC subgroup analysis, durvalumab plus BCG reduced the risk of high-risk recurrence or death by 44% vs BCG alone in patients with papillary-only, BCG-naive NMIBC.
Andrea Necchi, MD, discusses how results from the CA017-078 trials compares with other perioperative immunotherapy trials in muscle-invasive bladder cancer.
Advertisement
Advertisement