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Telix must resubmit the BLA with remediations in order to advance the application to full review, which the company expects to be able to complete within approximately 90 days.

“So, rather than waiting for men to proactively seek out mental health supports once they’ve been diagnosed with prostate cancer, we should be offering supports at the time of diagnosis and throughout treatment," says Kerri Beckmann, PhD.

"We wanted to look at the importance of genetic testing in patients with GU cancer and the impact that it has on their treatment decision-making, and the pathways that we put them on," says Mouneeb Choudry, MD.

Aspargo plans to file a new drug application with the FDA to support regulatory approval of ASP-001 for erectile dysfunction in the United States.

"One of the main conclusions that we can take from our study is that although the current classification systems are somewhat accurate, they are far from being perfect," says Félix Guerrero-Ramos, MD, PhD, FEBU.

"We can individualize the access and the way we do the operation based on the patient's characteristics, and that hasn't happened in a very long time," says Ketan K. Badani, MD.

The grants will support research evaluating ATAD2 in advanced prostate cancer and 6MP in hereditary leiomyomatosis and renal cell cancer.

"Teixobactin, and more broadly, the iChip approach to novel antibiotic discovery, is an exciting development in infection control," write Philip Abbosh, MD, PhD, and Kate Gessner, MD, PhD.

The CPT code 76377 may be used for ProstatID when the software is used in conjunction with a suitable CT, MRI, or a transrectal ultrasound.

A decision on the NDS for testosterone undecanoate is expected in Q2 of 2025.

“I think the use and the appropriateness of these agents along the patient journey is also coming into question,” says Brian T. Helfand, MD, PhD.

Data showed a patient-level detection rate of 93% with flotufolastat F 18 in African American patients.

"The CF for 2025 is proposed to decrease to $32.36 from $33.29 in 2024. This is a decrease of 2.80%," write Jonathan Rubenstein, MD, and Mark Painter.

"This study was looking at the incidence of cognitive impairment and/or manual dexterity disorder diagnoses in men who underwent an artificial urinary sphincter after treatment for prostate cancer," says Jacqueline Zillioux, MD.

Data showed that Hispanic patients were consistently underrepresented in clinical trials, while Black participants tended to be overrepresented.

"Nurse practitioners and physician assistants are considered qualified health care professionals and are able by license to supervise diagnostic tests and interpret based upon state laws," write Jonathan Rubenstein, MD, and Mark Painter.

“This highlights a need for physicians to better integrate patient preferences into their treatment recommendations," says Jonathan Bergman, MD, MPH.

The CHMP’s positive recommendation is based on findings from the first interim analysis of the phase 3 EV-302 trial.

"Stones that recur in children happen about 40% to 50% of the time. That's why the American Urological Association guidelines recommend doing a complete metabolic evaluation in all children," says Katherine Chan, MD, MPH.

“What our major contribution is, I think as urologists doing implementation science, is determining the important questions, which we are particularly well-suited to do because we're taking care of the patients,” says Danil V. Makarov, MD, MHS.

"Receiving the new CPT code and national payment rate for Unfold AI is an important development in making advanced personalized prostate cancer care accessible to more patients," said Brit Berry-Pusey, PhD.

"Documentation must support the existence and treatment of a separate stone," write Jonathan Rubenstein, MD, and Mark Painter.

In this episode of Speaking of Urology®, Ashley G. Winter, MD, discusses the use of vaginal estrogen.

The PDUFA goal date for TLX007-CDx is March 24, 2025.

"Going forward after this study, we hope to be able to expand and potentially look at patients undergoing either surgery or radiation therapy, and really try to determine the potential benefit," says Kelly L. Stratton, MD, FACS.

Data from phase 2 of the SANS-UUI trial are expected to support an application to the FDA for approval of the device in patients with urge urinary incontinence.

"This is an exciting step in the evolution of urological surgery for both adult and pediatric patients,” says Chester J. Koh, MD, MBA, FACS, FAAP.

"Although there is a good chance that you will face allegations of medical negligence at some point in your career, it is unlikely that you will ever be found liable by a jury," writes Victoria L. Neikam, Esq.