urologytimes

HHS requests testosterone therapy label updates, citing new safety data

Labeling would drop the limitation of use for age-related hypogonadism, reflecting an evidence reassessment that no longer supports language implying unestablished safety and effectiveness in this ...
urologytimes

The ArteraAI Prostate Test: What It Is and How It Works

Amar U. Kishan, MD, describes how the ArteraAI Prostate Test was built and validated, with particular attention to the RTOG 9408 data showing that more than 60% of intermediate-risk patients are ...
urologytimes

FDA gives nod to feasibility study of NanoKnife IRE for benign prostatic hyperplasia

RELIEF uses a prospective, single-arm design to generate initial safety and preliminary efficacy signals for transperineal transition-zone IRE as a non-resecting BPH/LUTS intervention. Eligibility ...
urologytimes

FDA approves tebipenem pivoxil for complicated urinary tract infections

The approval is supported by data from the phase 3 PIVOT-PO trial, in which tebipenem demonstrated noninferiority to imipenem-cilastatin. This decision marks the first approval of an oral carbapenem ...