UroGen Wins First FDA Approval With Jelmyto For Urothelial Cancer

Jelmyto relies on a proprietary sustained-release drug delivery technology that UroGen plans to use for future drugs. The company is moving ahead with a launch in June, relying on virtual technology. 

UroGen Pharma Ltd. is launching its first commercial drug following the US Food and Drug Administration approval of Jelmyto (mitomycin) for adults with low-grade upper tract urothelial cancer (LG UTUC). The company announced the approval after market close on 15 April and said it will aim to launch the drug on 1 June despite the ongoing COVID-19 pandemic.

"None of us could have anticipated that we would be executing a launch in the middle of a pandemic," CEO...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Removal Of REMS For CAR-Ts Could Greatly Expand Their Reach

 

The FDA eliminated REMS requirements for approved CAR-T cell therapies that have limited their availability, a move that could enable increased use in the community setting.

Deal Watch: Novartis To Develop Cardiovascular Therapies With ProFound

Plus deals involving BioCryst/Neopharmed Gentili, Sanofi/Kymera, Abion, Denovo/Chuang Yi, Carisma/OrthoCellix, Otsuka/Harbour Biomed, Aptose/Hanmi, Philochem/RayzeBio, Concentra/Elevation Oncology, and more.

What Incyte Investors Expect From New CEO Bill Meury

 

Fresh from having sold Anthos to Novartis, the new CEO is expected to update the oncology and dermatology-focused firm's strategy.