Hannah Clarke

However, this regimen was associated with substantial toxicity, so careful patient selection is paramount, according to the authors.

The objectives of the trial are to further confirm the recommended phase 2 dose and to assess the efficacy of MVR-T3011.

The NDA is supported by a pivotal phase 3 trial of zoliflodacin vs ceftriaxone plus azithromycin in patients with uncomplicated gonorrhea.

The regimen showed activity regardless of the prior immunotherapy-based combination used in the first-line setting.

In preclinical studies, ACE-232 demonstrated superior potency, efficacy, and pharmacokinetic properties compared with other CYP11A1 inhibitors.

The Cancer BioShield platform is being assessed as a treatment for lymphopenia in adult patients with refractory or relapsed solid tumors, including genitourinary tumors.

Data from the #HOPE4KIDNEY trial is intended to support submission for regulatory clearance of the Edison Histotripsy System.

Data showed that Non-Hispanic Black and Latinx/Hispanic patients were less likely to receive PSMA-PET imaging than non-Hispanic White patients.

The new drug application is backed by data from the phase 2/3 FRUSICA-2 trial.

According to the authors, the mitomycin/BCG regimen could alleviate some of the burden of the global BCG shortage.

“AMPLITUDE supports early genomic testing and niraparib plus AAP as a new treatment option for patients with mCSPC and HRR gene alterations," the authors wrote.

The approval is supported by data from the pivotal phase 3 ARANOTE trial.

According to the authors, these data continue to support enzalutamide plus ADT as a standard-of-care for patients with mHSPC.

"CAN-2409 immunotherapy could represent the first new therapy for men with localized prostate cancer in over 20 years," wrote the authors.

Data also showed a positive trend in overall survival.

Lower-dose abiraterone acetate was found to demonstrate comparable efficacy to standard-dose abiraterone.

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

"This final analysis of this study continues to support nivo+ipi as a standard of care for patients with untreated RCC," says Robert J. Motzer, MD.

According to the authors, these data reinforce EV plus pembrolizumab as the first-line standard of care for la/mUC.

The cCR rate was 44.4% in the intent-to-treat population.

The trial plans to enroll approximately 70 patients with mCRPC.

Overall, 59% of patients achieved at least a 50% decline in PSA level.

This year's meeting with feature several notable sessions in prostate cancer, bladder cancer, kidney cancer, and other GU malignancies.

The company plans to submit a Biologics License Application to the FDA at the end of 2026.

Further follow-up and additional treatments in the study are ongoing.

The approvals are supported by findings from the phase 3 CheckMate-67T trial.

These data are intended to support a new drug application to the FDA in the second half of 2025.

The single-use test can deliver diagnostic results for chlamydia and gonorrhea in approximately 30 minutes.

However, the data did not show any benefit of a docetaxel doublet vs an ARPI doublet.

James C. Ulchaker, MD, shares his insights on the current range of BPH therapies.