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.
Adam B. Weiner, MD, sits down with Giancarlo Marra, MD, at EAU 2026 to discuss transperineal vs transrectal biopsy for prostate cancer diagnosis. Mara highlights findings from a contemporary ...
VYBRIQUE is a sildenafil oral film formulated for discreet, water-free administration, aiming to reduce use barriers for patients for whom privacy and convenience influence ED treatment adherence. A ...
The Genomic Prostate Score (GPS) is being validated in the ProtecT trial to predict prostate cancer progression and treatment outcomes. ProtecT is a landmark phase 3 trial with over 1600 men, ...
FDA approved Gozellix for prostate cancer imaging and expanded 177Lu-PSMA-617's label for mCRPC treatment. 64Cu-SAR-bisPSMA demonstrated efficacy in detecting recurrent prostate cancer in the COBRA ...
AVZO-103 has received fast track designation for treating urothelial carcinoma, enabling accelerated development and review processes. The phase 1/2 trial will assess AVZO-103's safety, tolerability, ...
Non-muscle invasive bladder cancer treatments have expanded beyond BCG, offering alternatives to radical cystectomy with flexible dosing and scheduling. Muscle-invasive bladder cancer management is ...
Capivasertib addition to standard therapy extended rPFS by 7.5 months in PTEN-deficient metastatic hormone-sensitive prostate cancer. The trial showed consistent benefits across clinical endpoints, ...
Nocturnal enuresis affects millions, including adolescents and adults, and is not the child's fault but a sleep-related condition outside conscious control. Current treatments, including behavioral ...
AI tools like PathomIQ can predict prostate cancer metastasis by analyzing whole-slide images, independent of Gleason scores and gene expression profiling. Current AI applications in prostate cancer ...
ArteraAI Prostate is the first AI tool authorized to prognosticate long-term outcomes in localized prostate cancer, using multimodal AI technology. The FDA's de novo authorization allows ...
The STRIKE-001 trial evaluates KTX-2001, an NSD2 inhibitor, for mCRPC, with FDA clearance and collaboration with Bayer for darolutamide supply. The trial, managed by PCCTC, will enroll 144 patients, ...
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