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The approval is supported by data from the phase 3 EAGLE-1 trial.

Ibrahim explains the unique challenges men face after spinal cord injury, including neurogenic erectile dysfunction, ejaculatory dysfunction, and particularly the distinctive sperm abnormalities seen in this population.

In a panel meeting convened by the FDA, experts urged the agency to revise the current classification and indication for testosterone replacement therapy in men.

Daré Bioscience said the sildenafil cream’s availability will expand to other states throughout December 2025 and early 2026.

"If 2025 showed us anything, it is the power of combining scientific progress with public engagement," writes Michael S. Cookson, MD, MMHC, FACS.

The approval is supported by results from the randomized ProVIDE study.

The pilot study plans to enroll patients with locally recurrent prostate cancer across clinical trial sites in the US.

The FDA has selected detalimogene voraplasmid to participate in the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program.

The phase 1 study will assess the safety and feasibility of SPECT/CT imaging with [111In]In-ART-101.

DFS rate was 85.3% at 6 months (95% CI, 71.6-92.7), 74.3% at 12 months (95% CI, 59.2-84.6), and 69.2% at 18 months (95% CI, 53.4-80.6).

In patients with high-grade T1 disease, high-grade EFS was 100% and 3 months and at 6 months and 87.5% at 9 months.

Following treatment with SYNC-T, all bone metastases had resolved in 7 of the 13 patients.

The overall CR rate was 83.7% (95% CI, 70.3-92.7).

Forty-one of the 85 patients experienced disease persistence, progression, or recurrence.

CR at any time was 92% (23/25 patients), 84% (21/25) at 3 months, 87% (20/23) at 6 months, and 85% (17/20) at 9 months.

The data come just days after the FDA approved IsoPSA to aid in the diagnosis of high-grade prostate cancer.

For micro-ultrasound compared with true cancer status, estimated sensitivity was 0.8000.

The HCPs and AHCPs described insertion and removal of the system to be “straightforward” and done in less than 5 minutes.

At a median follow-up of 25.8 months, the CR rate at any time was 75.5%.

The safety and efficacy of the Hugo RAS system for urologic procedures was established in the Expand URO IDE study.

The investigators reported that new onset of CNS-related conditions was lower in patients in the apalutamide cohort at 12 months and 24 months post index.

The approval is supported by 12-month data from the prospective VAPOR 2 trial.

At a median follow-up of 18.8 months, the confirmed ORR was 31%.

"Once money is in a Roth IRA, the withdrawal rules depend on whether the funds are contributions, conversions, or earnings," writes Julie Khazan, CFP.

A recap of the FDA submissions and regulatory decisions in urology from November 2025.

The test is intended to aid in the decision for prostate biopsy in men aged 50 years or older who present with elevated PSA levels.

In this episode, Farnoosh Nik-Ahd, MD, joins host Adam Weiner, MD, to discuss emerging guidance on prostate cancer screening in transgender women.

"Based on the code description, we recommend basing the code selection on the documentation and the effort required to complete the service, and not the number of foreign bodies removed from the bladder," write Jonathan Rubenstein, MD, and Mark Painter.