urologytimes

FDA grants breakthrough device designation to Virtuoso Surgical Robotic System

The Virtuoso Surgical Robotic System received FDA breakthrough designation for bladder lesion removal, enabling expedited development and review processes. En bloc resection improves cancer staging ...
urologytimes

Phase 2 trial launches of CD46-targeting ADC in mCRPC

FG-3246 targets CD46 in mCRPC patients, focusing on those who progressed on ARSI without prior taxane therapy. The trial will evaluate FG-3246's safety, efficacy, and pharmacokinetics, alongside ...
urologytimes

Aleece Fosnight, MSPAS, PA-C, on stigma as a major barrier to incontinence care

Fosnight described how stigma itself becomes a barrier to care, even though effective diagnostic and treatment options are available. In an interview, Aleece Fosnight, MSPAS, PA-C, CSC-S, CSE, IF, ...
urologytimes

Ongoing clinical trials of BCG/ICI combinations in BCG-naïve NMIBC

Take a look through the key trials investigating BCG/ICI combinations in BCG-naïve NMIBC. In BCG-naïve non–muscle invasive bladder cancer (NMIBC), emerging options are largely focused on combining BCG ...
urologytimes

FDA grants clearance to BioTraceIO360 for kidney ablation

BioTraceIO360 received FDA 510(k) clearance for kidney ablation, expanding its previous liver tumor ablation indication. The platform standardizes minimally invasive care, enhancing treatment planning ...
urologytimes

FDA approves pembrolizumab for subcutaneous injection for solid tumors

The FDA approved subcutaneous pembrolizumab and berahyaluronidase alfa-pmph for solid tumors in patients 12 years or older. Recommended dosages are 395 mg/4800 U every 3 weeks or 790 mg/9600 U every 6 ...
urologytimes

Sigfred Ian R. Alpajaro, MD

Urology Times is the leading resource for urologists & allied health professionals offering clinical analysis, policy perspectives, & practical advice.
urologytimes

Physician-led implementation drives AI success in urology

Miles-Thomas emphasized the importance of Northwestern’s thoughtful implementation strategy. In a recent interview, Henry C. Wright IV, MD, and Jennifer Miles-Thomas, MD, URPS, MBA, highlighted ...
urologytimes

Key takeaways from the COMRADE trial in CRPC, with Rana McKay, MD

The combination of olaparib and radium-223 improved rPFS in CRPC patients with bone metastases compared to radium-223 alone. The greatest benefit was observed in patients without prior docetaxel ...
urologytimes

Updated BOND-003 data support durability of cretostimogene grenadenorepvec in NMIBC

Cretostimogene grenadenorepvec shows a 24-month complete response rate of 41.8% in high-risk BCG-unresponsive patients with NMIBC, with 90% of 12-month responders maintaining CR. The BOND-003 trial ...
urologytimes

FDA greenlights phase 1 trial of alpha radioligand therapy in mCRPC

AB001 is a novel PSMA-targeted radioligand therapy designed to treat metastatic prostate cancer with potentially higher tumor dose rates and lower normal tissue toxicity. The phase 1 trial will enroll ...
urologytimes

Sunobinop shows promising efficacy in interstitial cystitis/bladder pain syndrome

Sunobinop showed significant symptom improvement in 41% of IC/BPS patients versus 9% with placebo, indicating its potential efficacy. The investigational compound targets the NOP receptor, affecting ...