Hannah Clarke

Vesta Bladder Risk Stratify Dx applies AI foundation models to H&E pathology slides obtained during routine clinical care to generate prognostic risk assessments.

The agency issued a PDUFA target action date of January 6, 2027.

A comprehensive guide to the practice-changing, paradigm-shifting studies across benign urologic conditions.

With this expansion, the platform now represents a comprehensive automated testosterone testing solution.

A comprehensive guide to the practice-changing, paradigm-shifting studies across urologic oncology.

HistoSonics has submitted a de novo request to the FDA seeking an expanded indication for its Edison Histotripsy System.

The system is expected to launch initially within Veterans Health Administration spinal cord injury hospitals later in 2026.

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.