FDA grants breakthrough device designation for ArteraAI Prostate tool
“This designation is a powerful validation of our software's potential to transform how we treat cancer,” said Andre Esteva, CEO of Artera.
Data supports combination intravesical chemotherapy for high-risk NMIBC
“This study adds to the growing body of evidence supporting combination intravesical chemotherapy as a feasible option even after prior treatment failure," says Ian M. McElree, MD.
EMBARK: Significant OS gains seen with enzalutamide plus leuprolide in nmHSPC
According to the news release, detailed OS data from EMBARK are set to be presented at an upcoming medical conference.
FDA grants fast track designation to TRE-515 with 177Lu-PSMA-617 for mCRPC
The investigational treatment is being evaluated in phase 1 clinical trials for solid tumors.
Leva System adds Mayo Clinic overactive bladder content
Among the content is additional information on types of urinary incontinence, ways to control urgency, and frequently asked questions about a healthy bladder.
Optimizing SNM: PEER trials investigate potential of SNM lead sensing
Colin M. Goudelocke, MD, discusses the PEER trials, which are assessing the safety and efficacy of SNM lead sensing for optimizing SNM programming.
UK’s MHRA approves nogapendekin alfa inbakicept plus BCG in NMIBC
According to the company, the MHRA approval represents the first marketing approval outside the US for NAI.
Enrollment complete for phase 3 UTOPIA trial in LG-IR-NMIBC
Eligible patients will receive UGN-103 75 mg intravesically once per week for 6 weeks.
Zelenectide pevedotin plus pembrolizumab shows promising anti-tumor activity in mUC
The data, collected as part of the phase 1/2 Duravelo-1 trial, showed an objective response rate of 65%.
FDA and EMA authorize phase 3 trial of masitinib for mCRPC
For the trial, a biomarker will be utilized to aid in patient selection for the treatment.
Expanded indication sought for niraparib plus AAP in Europe
The application is supported by data from the phase 3 AMPLITUDE trial.
Regulatory recap: FDA approvals in urology from the first half of 2025
Take a look through all the regulatory milestones in urology from the first half of the 2025.
Top 10 Urology Times videos from the first half of 2025
Catch up on exclusive videos you may have missed from the first half of the year.
FDA news recap in urology for Q2 2025
Here’s a look back at notable news between April and June 2025.
da Vinci 5 Surgical System approved in Europe
The da Vinci 5 platform is approved for use across urologic, gynecologic, and general laparoscopic procedures in adult and pediatric patients.
RX Review: Implementing mitomycin for LG-IR-NMIBC in clinical practice
In this video, part 5 in a 5-part series, panelists examine the economic and logistical realities of bringing mitomycin for intravesical solution (Zusduri; formerly UGN-102) into private practice.
RX Review: TURBT vs chemoablation for low-grade, intermediate-risk NMIBC
In this video, part 4 in a 5-part series, Nick Liu, MD, outlines key scenarios where surgical resection remains preferred for treating LG-IR-NMIBC.
RX Review: A paradigm shift for low-grade, intermediate-risk NMIBC
In this video, part 3 in a 5-part series, panelists discuss the long-term clinical impact and health care system implications of mitomycin for intravesical solution (Zusduri; formerly UGN-102).
RX Review: How mitomycin for intravesical solution works in treating LG-IR-NMIBC
In this video, part 2 in a 5-part series, Nick Liu, MD, breaks down the formulation behind mitomycin for intravesical solution (Zusduri; formerly UGN-102).
RX Review: Redefining treatment for LG-IR-NMIBC
In this video, part 1 in a 5-part series, panelists discuss how mitomycin for intravesical solution (formerly UGN-102, now marketed as Zusduri) fits into the evolving management landscape for recurrent bladder tumors.
Enrollment begins in phase 2 trial of opaganib plus darolutamide in mCRPC
The study will utilize the companion lipid biomarker test, PCPro, to identify patients who may benefit from the addition of opaganib to darolutamide.
Study launches of first-in-class aromatase inhibitor for male infertility
The trial is evaluating the efficacy of leflutrozole in improving testicular function and promoting spermatogenesis.
Gedatolisib plus darolutamide shows encouraging activity in mCRPC
The combination demonstrated a 6-month radiographic progression-free survival of 66%.
FDA updates in urology: June 2025
A recap of the FDA submissions and regulatory decisions in urology from June 2025.
Pearls & Perspectives: Disruptive Innovation in Urology, with Sijo J. Parekattil, MD
Pearlman and Parekattil dig deep into novel surgical and non-surgical approaches to chronic orchialgia and pelvic pain.
FDA grants breakthrough device designation to urine test for bladder cancer detection
The TOBY test works by analyzing the molecular signatures of volatile organic compounds in urine.
Phase 2 trial of TYRA-300 launches in LG-IR-NMIBC
The primary end point for the trial is the complete response rate at 3 months.
What urologists can expect in Q3 of 2025
A comprehensive guide to the key regulatory decisions and conferences slated for Q3 of 2025.
Use of surgical therapy for erectile dysfunction remains low, study shows
The study also found racial differences in the time to proceeding with surgical therapy.
Biden’s prostate cancer diagnosis underscores importance of screening, awareness
The unfortunate news of President Biden’s diagnosis has put a spotlight on prostate cancer, offering an opportunity to educate on the risks of the disease and the benefits of screening.