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Abhishek Srivastava, MD, discusses the potential impact that UGN-103 might have on the treatment landscape for LG-IR-NMIBC.

"In my experience, when a treatment is well-tolerated and given on a predictable schedule, patients are more likely to adhere to therapy and remain engaged in long-term follow-up," Chauhan writes.

With this approval, flibanserin becomes the first and only treatment of its kind for women younger than 65 years.

The approval is supported by data from the phase 3 AMPLITUDE trial.

In a phase 3 trial, zoliflodacin demonstrated non-inferior efficacy compared with ceftriaxone plus azithromycin.

Nogapendekin alfa inbakicept was approved in combination with BCG in the US in April 2024.

Data from the pivotal BREEZE study indicated a mean IPSS improvement of 37% in patients receiving the system.

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.

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.

The investigators reported a high-grade CR rate at any time of 72.4% (21 of 29 patients).

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.

Complete response 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.

Health care providers and allied health care professionals described insertion and removal of the system as “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.