Hannah Clarke

The FDA has granted 510(k) clearance to the Glean Abdominal Sensor, expanding the capabilities of the Glean Urodynamics System.

Maria Carmen Mir, MD, PhD, discusses how phase 3 trials of BCG/ICI combinations are shaping the future of high-risk NMIBC management, emphasizing the need for a more selective approach to treatment intensification.

In a multisite validation study, the urine-based MPS2-AS assay outperformed mpMRI for detecting disease upgrading in men with GG1 prostate cancer on active surveillance and could reduce unnecessary biopsies.

The safety profile for BCG–gem/doce was favorable, which the authors suggested may “potentially increase compliance with maintenance regimens.”

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

The FDA Oncologic Drugs Advisory Committee voted 7-1-1 in support of a favorable risk-benefit profile for capivasertib plus abiraterone and prednisone in PTEN-deficient mHSPC.

Findings from the HIFI-2 study suggest that salvage HIFU provides meaningful mid-term oncologic control with an acceptable safety profile in patients with localized prostate cancer recurrence after radiotherapy.

The phase 2 trial will assess the safety and efficacy of ViXe, a product designed to deliver botulinum toxin directly into the bladder wall.

Neoadjuvant sacituzumab govitecan plus pembrolizumab yielded a clinical complete response rate of 39%, supporting the potential for bladder preservation.

Phase 1 data on 225Ac–J591 showed encouraging antitumor activity with manageable toxicity in patients with mCRPC.

Phase 3 LITESPARK-012 shows adding belzutifan or quavonlimab to pembrolizumab-lenvatinib fails to boost survival in first-line advanced clear cell RCC.

The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of JANX014 in patients with mCRPC.

Experts discuss the implications of the FDA’s potential pathway to expand testosterone replacement therapy labeling for low libido in men with idiopathic hypogonadism.

Adding pembrolizumab to trimodality therapy demonstrated encouraging activity in patients with muscle-invasive bladder cancer.

Fred Saad, MD, FRCS, discusses findings from a post hoc analysis of the phase 3 ARANOTE trial.

The assay is designed to detect multiple cancers, including prostate, bladder, and kidney cancer, through a simple, non-invasive urine sample.

In this interview, Brett Trockman, MD, FACS, details how shifting guideline recommendations and expanding treatment options are allowing for more personalized approaches to sacral neuromodulation.

Treatment with 177Lu-PSMA-617 may durably delay disease progression compared with deferred ADT in men with oligometastatic hormone-sensitive prostate cancer.

Investigators in the BioFront trial are evaluating whether CBM588 enhances the efficacy of immune checkpoint inhibitors in renal cell carcinoma.

Use of virtual reality for patient education before shock wave lithotripsy led to improved patient understanding and reduced anxiety.

The findings highlight the potential of field-effect-informed liquid biopsy methods to guide adjuvant treatment decisions in NMIBC.

David Morris, MD, FACS, highlights key strategies for counseling patients receiving the gemcitabine intravesical system as well as considerations for maintaining patients on therapy long enough to achieve meaningful clinical benefit.

ImmunityBio has submitted a formal response to the FDA and initiated corrective actions.