Hannah Clarke

The data come just days after the FDA approved IsoPSA to aid in the diagnosis of high-grade prostate cancer.

For micro-ultrasound compared with true cancer status, estimated sensitivity was 0.8000.

The HCPs and AHCPs described insertion and removal of the system to be “straightforward” and done in less than 5 minutes.

The safety and efficacy of the Hugo RAS system for urologic procedures was established in the Expand URO IDE study.

The approval is supported by 12-month data from the prospective VAPOR 2 trial.

At a median follow-up of 18.8 months, the confirmed ORR was 31%.

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

The test is intended to aid in the decision for prostate biopsy in men aged 50 years or older who present with elevated PSA levels.

At the 2025 LUGPA Annual Meeting, Joshua J. Meeks, MD, PhD, outlined the rapidly evolving treatment landscape in MIBC.

According to the authors, the optimal duration of treatment could be tied to individual patient factors such as cancer risk.

The authors suggested that a greater treatment effect may be observed with a more antigenic vaccine.

AVZO-103 is a Nectin-4/TROP2 biospecific antibody-drug conjugate for adult patients with urothelial carcinoma whose tumors have progressed on enfortumab vedotin.

The approval is supported by results from the phase 3 KEYNOTE-905/EV-303 trial.

Notably, 81% of patients said that they were interested in trying new or different treatment options.

In September 2024, the FDA granted an Orphan Drug Designation and a Rare Pediatric Disease Designation to YOLT-203 for PH1.

The clearance supports new ultrasound imaging and workflow enhancements to the Focal One i, which was launched earlier this year.

The ExactVu micro-ultrasound platform demonstrated noninferior detection of clinically significant prostate cancer vs MRI.

The subcutaneous formulation of pembrolizumab also received FDA approval in September 2025.

The test is designed to deliver actionable molecular results in approximately 15 minutes.

The CxBladder Triage Plus Test identifies patients with hematuria who are at higher risk for urothelial carcinoma.

[68Ga]Ga-DPI-4452 is a gallum-68-radiolabeled PET imaging agent that forms a theranostic pair with the therapeutic candidate, [177Lu]Lu-DPI-4452 (ITM-91).

The phase 1b trial is assessing ORIC-944 both in combination with darolutamide and apalutamide.

The safety and efficacy of testosterone undecanoate was demonstrated in the phase 3, six-month MRS-TU-2019EXT trial.

The rectal spacer showed sustained preservation of bowel, urinary, and sexual quality of life through 4 years of follow-up.

The agency is working with companies to update the language on HRT to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.

The FDA has confirmed that results from the UTOPIA trial can support submission of an NDA for UGN-103.

The study is assessing FL115 in combination with BCG in patients with non-muscle invasive bladder cancer.

The ENDURE 1 study plans to enroll up to 60 patients with benign ureteric strictures.

The approval is supported by the phase 2/3 ZEUS trial.

The phase 3 PSMAddition trial assessed the combination of 177Lu-PSMA-617 plus ADT/ARPI in an earlier stage of metastatic prostate cancer.