UroGen – Talk Bio

FDA Approves UroGen’s Chemo-Turned-Gel Drug ZUSDURI Despite Negative Advisory Vote

3 weeks ago talkbio0Tagged AdComm vote, Approved, chemo-turned-gel drug, Clinical Trials, ENVISION, intermediate-risk, low-grade, mitomycin, muscle-invasive bladder cancer, Negative, NON Mouse, ODAC, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen, ZUSDURI

UroGen; FDA approval; ZUSDURI; UGN-102; chemo-turned-gel drug; mitomycin gel; low-grade intermediate-risk non–muscle-invasive bladder cancer; negative AdComm vote; ENVISION trial; ODAC

FDA Advisory Committee Narrowly Votes Against UroGen’s Bladder Cancer Drug, Calls for Further Studies

1 month ago talkbio0Tagged Clinical Trials, Invasive, Malignant neoplasm of urinary bladder, mitomycin, Non-Muscle, Oncologic Drugs Advisory Committee, Pharma, RCT, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen

FDA; UroGen Pharma; UGN-102; bladder cancer; Oncologic Drugs Advisory Committee; mitomycin; RCT; non–muscle invasive bladder cancer; clinical trials

In first oncology expert meeting under Makary, FDA spotlights cancer drugs from J&J, Pfizer, Roche and UroGen

2 months ago talkbio0Tagged J&J, oncology expert, Pfizer, Roche (company), United States Food and Drug Administration, UroGen

United States Food and Drug Administration, oncology expert, J&J, Pfizer, Roche (company), UroGen