ScripOvercoming a negative US Food and Drug Administration advisory committee vote just weeks before, UroGen revealed on June 12 that Zusduri (UGN-102) was approved to treat patients with low-grade, interm
Pink SheetThe 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
Pink SheetA 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
Pink SheetThe 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