Hannah Clarke

[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.

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

According to the authors, immune-mediated adverse events were manageable and consistent with the known profiles for ICIs.

Avvio Medical plans to submit a de novo application for clearance of the device in early 2026.

Scott B. Sellinger, MD, FACS, discusses the challenges facing urologists, the loss of telehealth flexibility, and why bipartisan action remains urgent.

Merck plans to share these data with regulatory authorities worldwide.

The phase 3 LITESPARK-011 trial has met its primary end point.

Hear from 5 experts as they recap some of the top data from this year's ESMO Congress.

According to the authors, this combination represents a potential new standard of care for this patient population.

The code, J9282, will be effective on January 1, 2026.

Take a look through the top readouts in urologic oncology from ESMO 2025.

Three cycles of chemotherapy was shown to improve patient-reported outcomes vs six cycles, with no detriment to overall survival.

Initial data on pasritamig showed that the agent was well-tolerated and had encouraging preliminary anti-tumor activity in patients with mCRPC.

Data indicates that the DFS improvement was largely driven by the treatment effect in the higher risk population.

The PDUFA target action date for the application is April 7, 2026.

Data from the phase 3 ALBAN trial showed that atezolizumab plus BCG did not improve EFS compared with BCG alone.

The new CPT code will be effective starting on July 1, 2026.

The phase 2 Co-PSMA trial has met its primary end point.

The trial will assess the effect of adding docetaxel to SOC hormone therapy plus apalutamide in mCSPC.

The phase 1 trial is assessing VIR-5500 as both a monotherapy and in combination with ARPIs in prostate cancer.