Availability of estradiol transdermal patches is variable despite ongoing market presence, prompting FDA engagement with all 6 manufacturers to improve continuity of patient therapy. Heightened demand ...
A recap of the FDA submissions and regulatory decisions in urology from June 2026. Welcome to Urology Times’® monthly FDA update! June 2026 brought a wave of regulatory developments across the urology ...
The following FAQs highlight key recommendations and practical takeaways from the 2026 AUA/SUO Advanced Prostate Cancer Guideline. Two overarching themes define the 2026 amendment: the consolidation ...
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 ...
Pre-operative counseling should frame vasectomy as intended permanent contraception, individualized to reproductive goals, and can be delivered virtually or in person while directly addressing ...
The OPTIMUM randomized trial demonstrated that microultrasonography-guided biopsy is noninferior to MRI fusion-guided biopsy for detecting clinically significant prostate cancer, with a streamlined in ...
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 ...
Enolen's fast track designation by the FDA highlights its potential to address unmet needs in early-stage prostate cancer treatment. The implant technology aims to deliver high local drug ...
A recap of the FDA submissions and regulatory decisions in urology from December 2025. Welcome to Urology Times’® monthly FDA update! The year wrapped up with a flurry of regulatory approvals across ...
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 ...
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 ...
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