June 10th 2025
The NDA is supported by a pivotal phase 3 trial of zoliflodacin vs ceftriaxone plus azithromycin in patients with uncomplicated gonorrhea.
May 28th 2025
These data are intended to support a new drug application to the FDA in the second half of 2025.
May 1st 2025
A recap of the FDA submissions and regulatory decisions in urology from April 2025.
March 12th 2025
The method involves local delivery of the antibiotic gentamicin directly into the bladder tissue.
January 28th 2025
Check out the key regulatory decisions set to happen early this year.
Case-by-Case: Application of HIF-PHIs for the Treatment of Anemia in Patients With CKD
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Medical Crossfire® in Adjunctive Testing: Charting a New Course in Prostate Cancer Risk Assessment
FDA, French ANSM greenlight pivotal trial of UroActive smart implant for male SUI
FDA grants priority review to NDA for TAR-200 in BCG-unresponsive NMIBC
BCAN launches $1 million grant for bladder cancer research impacted by federal funding cuts
Meeting with FDA paves way for phase 3 trial of Alpha1H in NMIBC