Hannah Clarke

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.

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

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.

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).

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

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.

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

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%.

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.

At the 2025 LUGPA Annual Meeting, Joshua J. Meeks, MD, PhD, outlined the rapidly evolving treatment landscape in MIBC.

According to the authors, the optimal duration of treatment could be tied to individual patient factors such as cancer risk.

The authors suggested that a greater treatment effect may be observed with a more antigenic vaccine.

AVZO-103 is a Nectin-4/TROP2 biospecific antibody-drug conjugate for adult patients with urothelial carcinoma whose tumors have progressed on enfortumab vedotin.

The approval is supported by results from the phase 3 KEYNOTE-905/EV-303 trial.

Notably, 81% of patients said that they were interested in trying new or different treatment options.

In September 2024, the FDA granted an Orphan Drug Designation and a Rare Pediatric Disease Designation to YOLT-203 for PH1.

The clearance supports new ultrasound imaging and workflow enhancements to the Focal One i, which was launched earlier this year.

The ExactVu micro-ultrasound platform demonstrated noninferior detection of clinically significant prostate cancer vs MRI.

The subcutaneous formulation of pembrolizumab also received FDA approval in September 2025.

The test is designed to deliver actionable molecular results in approximately 15 minutes.