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In May 2024, the FDA cleared an investigational new drug application for 225Ac-FL-020.

“We go into medicine to take care of people and to help them, and when that doesn't transpire, it's a very tough reality,” says Aditya Bagrodia, MD, FACS.

"This clearance in the US of our new ureteroscopy solution not only demonstrates a market expansion for Ambu; it is a testament to the progressive shift towards single-use solutions within the field of urology," says Britt Meelby Jensen.

The decision is supported by findings from the phase 3 EMPOWUR trial and the phase 3 EMPOWUR extension study.

Earlier this year, the FDA cleared an investigational new drug application for SYNC-T SV-1022.

This announcement follows an earlier FDA decision to grant approval to the company’s tissue-based comprehensive genomic profiling test FoundationOne CDx for the same therapy and indication in August 2023.

CBM588 could be exciting in cancer treatment because of its potential to enhance the efficacy of immune checkpoint inhibitor-based treatment, improve patient outcomes, and modulate the gut microbiota in beneficial ways,” says Sumanta Pal, MD.

The positive CHMP opinion is supported by findings from cohort 1 of the phase 3 THOR trial.

"The addition of efficacy data from the KEYNOTE-B61 trial reinforces the important role of KEYTRUDA plus LENVIMA as a frontline treatment option for adult patients with advanced RCC regardless of histology," says Takashi Owa, PhD.

Urology Times’ exclusive survey reveals urologists/advanced practice providers’ thoughts on reusable vs disposable cystoscopes.

"Using this as an adjunctive test after PSA screening will give physicians more information to help decide if their patient should undergo a prostate biopsy or not,” says M. Eric Hyndman, MD, PhD, FRCSC.

“The MAT2A-Trop2 ADC combination targets 2 distinct, yet complementary nodes in patients with MTAP-deleted urothelial cancer and has first-in-class potential to improve clinical outcomes for bladder cancer patients with poor prognosis associated with MTAP-deletion," says Darrin M. Beaupre, MD, PhD.

“Even when we adjusted for other clinical variables, like age or grade of tumor, this signature was still independently associated with recurrence after treatment for this form of kidney cancer," says Simpa S. Salami, MD, MPH.

The UroActive System is currently under investigation in 2 first-in-human clinical trials in male and female patients with SUI.

“These NIAGARA data show for the first time that adding durvalumab to chemotherapy before surgery followed by durvalumab extends patients’ lives," says Thomas Powles, MD.

A phase 1 trial of ADI-270 in clear cell RCC is expected to launch in the second half of 2024.

The fast track designation for BNT324/DB-1311 is supported by safety and efficacy data from an ongoing phase 1/2 trial of the ADC in patients with advanced/metastatic solid tumors.

"Looking at data, if you apply IsoPSA in a consistent manner, based on the studies published, you'll see up to a 55% reduction in unnecessary biopsies," says Jason M. Hafron, MD.

The bill has a mass of legislative supporters – at least 41 senators and 127 representatives, along with more than 370 organizations representing patients, physicians, hospitals and Medicare Advantage plans.

Data from SEER showed a median OS of 23.0 months between the years 2000 to 2004 in patients with mHSPC, which increased to 30.0 months in 2015 to 2019.

Subcutaneous nivolumab is also under review in the United States based on findings from the phase 3 CheckMate-67T trial.

"The medical necessity of the service needs to be expressed within the documentation submitted," write Jonathan Rubenstein, MD, and Mark Painter.

N-803 was approved by the FDA in April 2024 for the treatment of patients with BCG-unresponsive NMIBC carcinoma in situ with or without papillary tumors.

A novel co-formulation of bremelanotide and a PDE5 inhibitor allows the treatment to be administered to patients via a single injection.

Patients in the Cxbladder arm had a 59% relative reduction in the number of cystoscopies performed vs those in the control arm.

"As the markets continue to push record highs, staying disciplined in your investment strategy, removing emotion from your decision-making, and sticking to an appropriate investment allocation will be vital to navigating market swings," writes Jeff Witz, CFP.

"This study reinforces our role as physicians to guide patients away from costly supplements with little or no benefit," said Wai Lee, MD.

"I think digital therapeutics and virtual care are going to expand access," says David Sheyn, MD.