The target action date for the application is March 6, 2026.

In the phase 3 RC48-C016 study, disitamab vedotin plus toripalimab significantly improved PFS and OS vs chemotherapy.

In this interview, Tom Jayram, MD, offers insights into how BCG plus immune checkpoint inhibitors may redefine the treatment landscape in BCG-naïve NMIBC.

A phase 3 registrational trial of NDV-01 is expected in the first half of 2026.

"It is common for a payer to request patient records when submitting for a service with a category III code," write Jonathan Rubenstein, MD, and Mark Painter.

New findings from the PKIDS trial raise questions about the preference for ureteroscopy in clinical practice.

Take a look through key stories from last month, including regulatory news, trial updates, and other practice-changing advancements.

The phase 1 STRIKE-001 trial will evaluate KTX-2001 as both a monotherapy and in combination with darolutamide.

Data from the phase 2 EXTEND trial showed that the addition of metastasis-directed therapy to ADT improved measures of systemic disease control.

Take a look through key stories from last month, including regulatory news, trial updates, and other practice-changing advancements.

"What we showed was that there's no difference in the pressures whether you use CVAC or standard ureteroscopy," says Roger Sur, MD.

FX-909 is an investigational small molecule PPARG inhibitor for patients with locally advanced or metastatic urothelial carcinoma.

Treatment with mitomycin for intravesical solution led to a 24-month DOR of 72.2% among patients who achieved an initial complete response.

"Major complications of ring pessaries are rare but present considerable challenges to surgeons and patients when they do occur," write E. Mackenzie Gibbs, MD, and Charles Lloyd Secrest, MD.

Five-year data from the phase 3 KEYNOTE-426 trial confirm the clinical benefits of front-line pembrolizumab plus axitinib in advanced ccRCC.

INKmune was well-tolerated across all 3 dose levels assessed.

"As with all medications and services, it is important to check with the patient’s insurer to determine their policy and whether the medication will be covered," write Jonathan Rubenstein, MD, and Mark Painter.

Data showed that 1 in 6 men with GG1 prostate cancer ultimately had higher-risk disease when other clinical features were taken into account.

A recap of the FDA submissions and regulatory decisions in urology from July 2025.

Data show that TAR-200 monotherapy led to high complete response rates and encouraging DFS in patients with BCG-unresponsive high-risk NMIBC.

ATNM-400 demonstrated improved efficacy compared with 177Lu-PSMA-617 in treatment-resistant models as well as enhanced efficacy in combination with enzalutamide.

The first patient has been dosed in the phase 1/2 redePHine trial, evaluating the safety and preliminary efficacy of ABO-101 for PH1.

Enzalutamide plus ADT was associated with significant improvements in rPFS and time to castration resistance compared with darolutamide plus ADT.

The 500 mg regimen of abiraterone acetate demonstrated comparable anti-tumor activity and a favorable safety profile compared with the standard 1000 mg dose.

Bansal unpacks how to personalize treatment plans in a therapeutic landscape now filled with minimally invasive and surgical options.