Flibanserin (Addyi) is now approved for treating HSDD in postmenopausal women, expanding its previous indication for premenopausal women. The FDA's priority review designation for flibanserin ...

Mohit Khera, MD, MBA, MPH, recaps key takeaways from an FDA expert panel discussion on testosterone replacement therapy for men. In a recent interview with Urology Times®, Mohit Khera, MD, MBA, MPH, ...

The ProVee System received FDA approval for treating BPH, offering a safe and effective procedure for symptom relief and quality of life improvement. The ProVIDE study showed significant improvement ...

IsoPSA test analyzes prostate cancer-specific structural variants of PSA protein to aid biopsy decisions in men over 50 with elevated PSA levels. The FDA approved IsoPSA based on a large-scale, ...

MRI outperformed micro-ultrasound in sensitivity and negative predictive value for prostate cancer detection. Micro-ultrasound offers a short learning curve and real-time lesion identification, ...

Panelists discuss how the recent FDA approval of darolutamide for metastatic hormone-sensitive prostate cancer (mHSPC) expands treatment options, offering improved tolerability with lower fatigue ...

Alicia Morgans, MD, MPH, and Paul Sieber, MD, introduce the discussion, outlining goals to connect evolving mCRPC research with personalized immunotherapy practice. The experts conclude with a forward ...

The approval is supported by results from the phase 3 KEYNOTE-905/EV-303 trial. On November 21, 2025, the FDA approved pembrolizumab (Keytruda) and pembrolizumab and berahyaluronidase alfa-pmph ...

Most NMIBC patients rely on healthcare providers for treatment decisions, but desire more comprehensive discussions about options. Patients prefer treatments beyond chemotherapy, with 81% interested ...

YOLT-203 is an investigational gene-editing therapy for PH1, aiming to reduce oxalate overproduction by deactivating glycolate oxidase. The pivotal trial will assess YOLT-203's safety and efficacy in ...