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A recap of the FDA submissions and regulatory decisions in urology from March 2026.

The first patients have been treated in WOLVERINE, a prospective feasibility trial of the Edison Histotripsy System for BPH.

Take a look through the top 10 stories in urology from the past quarter.

A recap of the FDA approvals and clearances across urology from January through March.

The device will be available over the counter in the US, with anticipated availability beginning in April 2026.

At 3 years, transdermal estradiol demonstrated noninferior MFS compared with standard LHRH agonists.

The study is evaluating the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD 402 in patients with locally advanced or metastatic castration-resistant prostate cancer.

The system can be used as an irrigation option for ureteroscopy, cystoscopy, percutaneous nephrolithotomy, and benign prostatic hyperplasia procedures.

Andrew J. Armstrong, MD, MS, highlights updated recommendations from the Prostate Cancer Working Group 4.

In this episode of The UroOnc Minute, host Adam B. Weiner, MD, is joined by Veeru Kasivisvanathan, MBBS, MSc, PhD, FRCS, to discuss the role of biparametric vs multiparametric MRI for prostate cancer detection.

Kuang and the AACU assert that although the clinical dialogue should begin between the ages of 45 and 60, dialogue alone cannot solve the crisis without the infrastructure to support it.

This episode reflects a broader shift in the field: a move toward diagnostics that are not only more accurate, but also more human-centered.

The company remains on track to submit a supplemental Biologics License Application in the fourth quarter of 2026.

The 5-factor model aims to refine treatment decision-making by stratifying patients into 3 clinically actionable subgroups.

The label update permits thawing of nadofaragene in a 25 °C water bath over approximately 25 minutes.

Findings from a systematic review suggest that increased fluid intake, dietary modification, and selected pharmacologic therapies may reduce recurrence of kidney stones in adults.

The European Commission is expected to have a final decision on the application in the second quarter of 2026.

Two new analyses from the ASPIRE trial showed lower health care consumption events and reduced follow-up costs with the SURE procedure vs URS, with RSV emerging as a key predictor of long-term utilization.

The results highlight the complexity of secondary prevention in stone disease.

The NCCN now assigns a Category 2A recommendation for nadofaragene in patients with high-risk BCG-unresponsive NMIBC with papillary tumors without CIS.

Topline results from the TALAPRO-3 study showed that adding talazoparib to enzalutamide improved rPFS for patients with HRR-mutated mCSPC.

At EAU 2026, Adam B. Weiner, MD, spoke with Nikita Bhatt, MD, about the growing interest in prehabilitation to optimize patients ahead of cystectomy.

Enolen implants demonstrated minimal systemic drug exposure and early signals of tumor volume reduction in localized prostate cancer.

The NCCN has recognized NAI plus BCG as an option for BCG-unresponsive papillary NMIBC as FDA review continues.

The OPTIMUM randomized trial demonstrated that microultrasonography-guided biopsy is noninferior to MRI fusion-guided biopsy for detecting clinically significant prostate cancer, with a streamlined in-office workflow, a manageable learning curve, and substantially lower cost that may help address diagnostic access gaps worldwide.

64Cu-SAR-bisPSMA demonstrated higher lesion detection rates, improved diagnostic accuracy, and a substantial impact on clinical management.

Adam B. Weiner, MD, sits down with Giancarlo Marra, MD, at EAU 2026 to discuss transperineal vs transrectal biopsy for prostate cancer diagnosis.

A subgroup analysis of the POTOMAC trial showed that durvalumab plus BCG I+M had consistent safety and efficacy in older patients with BCG-naïve high-risk NMIBC.