Labeling would drop the limitation of use for age-related hypogonadism, reflecting an evidence reassessment that no longer supports language implying unestablished safety and effectiveness in this ...

Praful Ravi, MB, BChir, MRCP, discusses results from PSMAtrack, which assessed changes in PSMA-PET during initial systemic therapy for metastatic hormone-sensitive prostate cancer. According to Ravi, ...

FDA approval positions Titan Prime as Coloplast’s updated IPP option for men with severe erectile dysfunction seeking long-term prosthetic restoration of erectile function. Improved flaccid ...

Dose escalation to 10 MBq produced no DLTs and no MTD, with grade ≥3 TRAEs in 11%–24% and rare AE-driven discontinuations. Xerostomia occurred in approximately 90% to 97% of patients, remained grade 1 ...

Isaac Y. Kim, MD, PhD, MBA, reflects on concerning trends in prostate cancer mortality, emphasizing how advances in diagnostics, treatment, and artificial intelligence may improve outcomes in the ...

Breakthrough Device Designation may streamline development via enhanced FDA engagement and priority review for a platform positioned as a step-change versus incremental screening improvements.

High-powered holmium and thulium laser platforms are expanding ureteroscopic options for complex patients, including those on anticoagulation, while emerging technologies such as Break Wave ...

FDA 510(k) clearance enables use of external neuromuscular stimulation to strengthen pelvic floor musculature and improve bladder control in men with post-prostatectomy incontinence. Daily home ...

Dinesh Singh, MD, emphasizes that radiation reduction begins at the diagnostic stage, favoring low-dose CT scans over standard-dose imaging. In this video, Dinesh Singh, MD, associate professor of ...

A central theme is the widening gap between clinical work and health care policy. In this episode of The Expert APProach: Conversations in Uro-Oncology, the conversation expands beyond clinical care ...

Boxed warnings were removed from Prometrium, Divigel, Cenestin, Enjuvia, Estring, and Bijuva, spanning progestogen-only, systemic estrogen-only, topical vaginal estrogen, and combined systemic ...

GSK resubmitted an NDA for tebipenem pivoxil hydrobromide to the FDA for cUTI treatment, including pyelonephritis. The phase 3 PIVOT-PO trial showed tebipenem HBr's noninferiority to ...