Among patients with non–muscle-invasive bladder cancer, neoadjuvant mitomycin demonstrated favorable safety. Among patients with non-muscle-invasive bladder cancer (NMIBC), neoadjuvant treatment with ...

UroGen’s shares drop 20% as the FDA raises concerns about the trial design for UGN-102 bladder cancer treatment.

As the FDA prepares for a busy Oncologic Drugs Advisory Committee meeting next week, an agency insider told BioSpace that ...

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for ...

Immune checkpoint inhibitors have shown a survival benefit in patients with metastatic urothelial cancer, so investigators trialed neoadjuvant nivolumab and ipilimumab in patients with muscle-invasive ...

UGN-102 is UroGen’s sustained-release formulation of mitomycin, being developed for recurrent low-grade, intermediate-risk, non-muscle-invasive bladder cancer (LG-IR-NMIBC). Among the 41 ...

“Low-grade bladder cancer is a persistent cancer that frequently recurs and comes with its own risks. There is a significant unmet need in finding treatment options for patients with recurrent ...

And if the drug – their combination gets approved with a single-agent mitomycin that stays in your bladder about four hours, then a single-arm trial in that setting with our formulation makes a ...

“We are excited to discuss our data with the Advisory Committee and broader medical community as we continue our mission to bring innovative solutions to patients suffering from bladder cancer ...