The NDA is supported by data from cohort 2 of the phase 2b SunRISe-1 trial.

The Mona Lisa 2.0 platform has been previously approved in the US, Australia, and Singapore.

“In this phase 2 study, an image-guided adaptive strategy enabled radiotherapy dose escalation to over 86% of patients’ bladder tumors without significant increase in toxicity,” wrote the authors.

In a recent study of the RELIEF stent, 95% of patients showed no VUR following stent placement.

The PDUFA target action date has been set for August 29, 2025.

The Expander-2 trial is intended to provide data that will support submission of the device for regulatory approval.

"The increasing expenses associated with bladder cancer treatment highlight wider issues regarding the sustainability of health care expenditures in the US," writes Michael S. Cookson, MD, MMHC, FACS.

The test can provide results in 48 minutes to provide diagnostic insights for conditions such as hypogonadism, impotence, polycystic ovarian syndrome, and other androgenital syndromes.

Results from CREST will be presented at an upcoming medical conference.

"We expect to initiate patient dosing in the second quarter of this year, with initial three-month [complete response] data to follow," says Doug Warner.

9MW2821 was previously awarded a breakthrough therapy designation as a monotherapy for locally advanced or metastatic urothelial carcinoma.

Following an initial dose of VIR-5500 of 120 µg/kg or higher, all patients achieved a PSA reduction.

At a median follow-up of 33.2 months, the confirmed objective response rate was 73.2%.

The NMPA’s approval was supported by data from the phase 3 EV-302 trial.

Sunobinop resulted in a reduction in urinary urgency, urinary frequency, and incontinence episodes over the treatment period compared with placebo.

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

The J-code became effective on January 1, 2025.

"The goal for this study was to understand, over the lifetime in individuals with spina bifida, what bacteria are present in their urine normally, what bacteria are present when they have a UTI, and what are some important clinical differences we can tease out to help understand which patients should really be treated," says Brendan T. Frainey, MD.

"When I eventually met Das at an AUA annual meeting, his smile and demeanor were captivating. I had to push through the hordes of admirers to get close to him," writes Gopal H. Badlani, MD.

“However, it was informative to uncover such a high number of metastatic findings in a well-defined cohort of patients resembling the EMBARK trial population that was supposed to only include those without metastases," says Adrien Holzgreve, MD, MHA.

The detection rate for [99mTc]Tc-HYNIC-iPSMA SPECT imaging was 77.5%.

Among those with Signature II tumors, overall survival was improved among those who received nivolumab compared with those who received everolimus.

The BLA for TLX250-CDx was initially submitted to the FDA in June 2024.

Catch up on all the notable drug and device approvals in urology over the past year.

"If a practice has determined in writing that there are insurers whose policies advised that they will not accept this code, it seems reasonable not to report that code to that insurer even when criteria are met," write Jonathan Rubenstein, MD, and Mark Painter.