The agency issued a PDUFA target action date of June 14, 2027. The FDA has accepted for review a new drug application (NDA) seeking approval of UGN-103 (mitomycin) for intravesical solution for ...
Take a look through some of the notable data presentations at this year's ESMO Congress. Taking place October 23 to 27 in Madrid, Spain, the 2026 European Society for Medical Oncology (ESMO) Congress ...
Long-term QUILT-3.032 findings show durable responses with Anktiva plus BCG in BCG-unresponsive NMIBC, with an estimated 84.2% cystectomy-free survival at 3 years. Nogapendekin alfa inbakicept ...
These FAQs outline key recommendations and practical takeaways from the AUA/SUO guideline amendment on the diagnosis and treatment of NMIBC. The management of non–muscle invasive bladder cancer (NMIBC ...
Fast track status enables frequent FDA engagement and may support accelerated approval or priority review for prebiopsy 68Ga-PSMA-11 imaging. BiPASS is a prospective, open-label, multicenter phase 3 ...
PACE-A randomized surgery-eligible cT1c–T2c, Gleason ≤3+4, PSA ≤20 ng/mL patients to prostatectomy versus 5-fraction SBRT without ADT, enabling direct efficacy and toxicity comparisons.
A recap of the FDA submissions and regulatory decisions in urology from September 2026. Welcome to Urology Times’® monthly FDA update! This month’s regulatory news featured new and expanded treatment ...
Farah Rahman, MD, MPH, highlights a pilot study on the use of wearable biofeedback technology to better understand and address burnout among urology residents. Sudha Jayaraman, MD, MSc, FACS, recaps a ...
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