Benign Conditions

The FDA approved cefepime and zidebactam for adult complicated UTI after ENHANCE-1 showed an 89.0% response rate at test of cure.

A comprehensive guide to the practice-changing, paradigm-shifting studies across benign urologic conditions.

The system is expected to launch initially within Veterans Health Administration spinal cord injury hospitals later in 2026.

The FDA has granted 510(k) clearance to the Glean Abdominal Sensor, expanding the capabilities of the Glean Urodynamics System.

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

The application is supported by results from the phase 3 PIVOT-PO trial.

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

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

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

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

The ENDURE 1 study plans to enroll up to 60 patients with benign ureteric strictures.

The approval is supported by the phase 2/3 ZEUS trial.

Take a look back at the notable regulatory decisions in benign urology between July and September.

We recap notable headlines from last month in the benign urology space.

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

The device features a 12 French working channel, the largest of any flexible single-use cystoscope.

A comprehensive guide to the key regulatory decisions and conferences slated for the last few months of the year.

Data showed a marked or moderate improvement in IC/BPS symptoms in 41% of patients who received sunobinop vs 9% of patients who received placebo.

The approval of oral sulopenem was supported by data from the phase 3 SURE 1 (NCT03366207) and REASSURE (NCT05584657) trials.

The target action date for the application is December 11, 2025.

Take a look through key stories from last month, including regulatory news, trial updates, and other practice-changing advancements.

Howard B. Goldman, MD, discusses the rationale and development process for the Glean Urodynamics System.

The NDA is supported by a pivotal phase 3 trial of zoliflodacin vs ceftriaxone plus azithromycin in patients with uncomplicated gonorrhea.

These data are intended to support a new drug application to the FDA in the second half of 2025.

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