Hannah Clarke

The combination also yielded durable responses in a subset of patients with sporadic papillary renal cell carcinoma.

CG Oncology plans to initiate a BLA submission with the FDA in Q4 of 2025.

The AUA has released updated guidelines for recurrent UTIs in women, emphasizing patient-centered care, nonantibiotic options, and improved clinical judgment.

The LEGEND trial is evaluating detalimogene voraplasmid in patients with high-risk non–muscle invasive bladder cancer.

The trial is assessing RFS rates with cretostimogene grenadenorepvec vs surveillance following TURBT.

The report showed rising incidence rates and a slowing of mortality declines in addition to persistent racial disparities.

Take a look through key stories from last month, including regulatory news, trial updates, and other practice-changing advancements.

Predicine has submitted the first module of a PMA application for their urine cfDNA NGS assay PredicineCARE.

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

The new guidelines provide evidence-based recommendations for treating patients with traumatic injuries to the kidneys, bladder, ureters, urethra, and genitalia.

The approval is supported by findings from an open-label, single-arm, phase 3 trial.

The findings highlight a lack of awareness on the signs and symptoms of prostate cancer, as well as common misconceptions about testicular cancer.

The FDA has declined to approve 89Zr-DFO-girentuximab for PET imaging of ccRCC.

The findings were derived from the multicenter, prospective, phase 3 STAMPEDE trial.

“This shows that AI analysis of routine biopsies can detect subtle signs indicating clinically significant prostate cancer before it becomes obvious to a pathologist," says Carolina Wählby, PhD.

Take a look through the novel agents that are set to further redefine the treatment landscape for high-risk BCG-unresponsive NMIBC.

Darolutamide plus ADT has also been approved in the US as well as in the European Union.

“We hope our findings reassure health professionals caring for postmenopausal women with a history of stroke,” says Kimia Ghias Haddadan, MD.

The presentations featured data on the drug candidate BOTRESO for BPH and LUTS, as well as on the prostate cancer prevention drug MCS-8.

The company is engaged in discussions with the FDA surrounding the initiation of a pivotal phase 3 trial of Alpha1H.

Concurrent use of an ARPI with [177Lu]Lu-PSMA-617 did not improve response rates nor overall survival in patients with ARPI-refractory mCRPC.

The approval of oral sulopenem was supported by data from the phase 3 SURE 1 (NCT03366207) and REASSURE (NCT05584657) trials.

The findings suggest that urolithiasis continues to pose a significant healthcare burden worldwide.

Patients who were Signatera positive and received treatment with atezolizumab had a statistically significant and clinically meaningful improvement in DFS and OS.

According to the authors, these data support the value of PSMA PET/CT in the pre-salvage radiotherapy selection process.

The ARCHER trial is seeking to determine whether ultra-hypofractionated radiotherapy is non-inferior to hypofractionated radiotherapy in terms of bladder-intact event-free survival.

The agent is currently being evaluated in a phase 1/2 trial.

Urologists from the University of North Carolina share insights into key advancements across the field of urologic oncology.

The ArteraAI test is now the first and only AI-powered tool to be authorized to prognosticate long-term outcomes in patients with localized prostate cancer.

The target action date for the application is December 11, 2025.