Hannah Clarke

The PRESERVE trial met its primary end point by demonstrating a negative in-field biopsy rate of 71% at 12 months.

According to the authors, these data support Rezūm as an alternative first-line treatment option for patients at risk of BPH progression.

This approval enables the use of darolutamide plus ADT with or without chemotherapy.

Mitomycin intravesical solution was granted FDA approval in June 2025 for recurrent LG-IR-NMIBC.

In a panel meeting convened by the FDA, experts urged the agency to revise or remove the outdated boxed warning on hormone therapies for menopause.

In both cohorts, the combination of talazoparib plus enzalutamide led to a significant improvement in overall survival vs enzalutamide alone.

Take a look back through some of the top stories from the first half of the year.

The phase 2 Co-PSMA trial enrolled 50 patients with biochemical recurrence of prostate cancer.

The SOPHIA2 trial will assess the safety and efficacy of the UroActive implant in men with SUI.

The new drug application for TAR-200 is supported by data from cohort 2 of the phase 2b SunRISe-1 trial.

The Continuity Grant will support projects in bladder cancer and/or upper tract urothelial carcinoma that were previously scientifically reviewed, approved, and funded.

Alpha1H was granted a fast track designation in November 2023.

The level II code A9616 will be effective starting on October 1, 2025.

The company said it plans to report interim efficacy data from the trial in September 2025.

“Our data support adherence to guideline recommendations for treatment of prostate cancer,” says Pietro Scilipoti, MD.

In healthy aging men without developing diabetes mellitus, modest increases in HbA1c were linked with declines in sperm motility and erectile function.

“This designation is a powerful validation of our software's potential to transform how we treat cancer,” said Andre Esteva, CEO of Artera.

“This study adds to the growing body of evidence supporting combination intravesical chemotherapy as a feasible option even after prior treatment failure," says Ian M. McElree, MD.

The investigational treatment is being evaluated in phase 1 clinical trials for solid tumors.

Among the content is additional information on types of urinary incontinence, ways to control urgency, and frequently asked questions about a healthy bladder.

Colin M. Goudelocke, MD, discusses the PEER trials, which are assessing the safety and efficacy of SNM lead sensing for optimizing SNM programming.

According to the company, the MHRA approval represents the first marketing approval outside the US for NAI.

Eligible patients will receive UGN-103 75 mg intravesically once per week for 6 weeks.

The data, collected as part of the phase 1/2 Duravelo-1 trial, showed an objective response rate of 65%.

The application is supported by data from the phase 3 AMPLITUDE trial.

Take a look through all the regulatory milestones in urology from the first half of the 2025.

Here’s a look back at notable news between April and June 2025.

The da Vinci 5 platform is approved for use across urologic, gynecologic, and general laparoscopic procedures in adult and pediatric patients.

The study will utilize the companion lipid biomarker test, PCPro, to identify patients who may benefit from the addition of opaganib to darolutamide.

The trial is evaluating the efficacy of leflutrozole in improving testicular function and promoting spermatogenesis.