UroGen Pharma, Ltd.

The US Food and Drug Administration’s June user fee goal calendar reflects the gravitational pull of major meetings. The month opens with the monster American Society of Clinical Oncology annual meeti

A US Food and Drug Administration advisory committee was divided on the approvability of UroGen Pharma ‘s UGN-102 for low-grade, intermediate risk, non-muscle invasive bladder cancer, as well as a po

The US FDA’s Oncologic Drugs Advisory Committee fully supported the importance of prospectively screening and pre-specifying biomarker subgroups as part of its unanimous rejection of Pfizer ‘s bid to

Future approval standards for drugs treating low-grade, intermediate-risk, non-muscle invasive bladder cancer (LG-IR-NMIBC) will be at issue during a US Food and Drug Administration advisory committee