July 7th 2025
For the trial, a biomarker will be utilized to aid in patient selection for the treatment.
The application is supported by data from the phase 3 AMPLITUDE trial.
July 4th 2025
Take a look through all the regulatory milestones in urology from the first half of the 2025.
Catch up on exclusive videos you may have missed from the first half of the year.
July 3rd 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.
Genomic test can predict resistance to chemotherapy in prostate cancer
The test utilizes chromosomal instability signatures to predict resistance to taxane-based chemotherapy in metastatic prostate cancer.
177Lu-rhPSMA-10.1 injection shows positive radiation dosimetry results in mCRPC
The results demonstrated a favorable ratio between radiation doses absorbed in the tumor vs the doses delivered to key healthy organs.
Phase 3 data of oral sulopenem for uUTIs published in NEJM Evidence
Oral sulopenem was approved by the FDA in October 2024 for the management of uUTIs.
FDA grants RMAT designation to detalimogene voraplasmid for high-risk NMIBC
Detalimogene is currently under evaluation in the pivotal phase 1/2 LEGEND trial.
Botulinum toxin reduces PSMA therapy-related salivary gland toxicity
The approach was associated with a 30% decrease in PSMA uptake by the salivary glands without compromising the treatment’s efficacy.
The C1769 prior authorization puzzle: A billing challenge
"We have received numerous complaints about the PA and predetermination process. We all wish we could answer this differently and definitively," write Jonathan Rubenstein, MD, and Mark Painter.
Trial launches of diagnostic agent for clear cell renal cell carcinoma
Arm D of the trial is assessing the performance of [68Ga]Ga-DPI-4452 in detecting ccRCC in patients with an indeterminate renal mass.
The future of OAB treatment: Emerging nerve targets and AI may guide therapy
Howard B. Goldman, MD, FACS, discusses innovations such as tibial nerve stimulation devices, pudendal nerve targeting, and alternative stimulation frequencies.
FDA expands Illuccix label to include patient selection for RLT in pre-taxane setting
The label expansion follows the FDA approval of an expanded label for 177Lu-PSMA-617 for use in patients with mCRPC after ARPI therapy and before chemotherapy.
FDA and EMA authorize phase 3 trial of masitinib for mCRPC
Expanded indication sought for niraparib plus AAP in Europe
Regulatory recap: FDA approvals in urology from the first half of 2025
Top 10 Urology Times videos from the first half of 2025