ODAC – Talk Bio

FDA Advisory Committee Votes Against GSK’s Blenrep in Multiple Myeloma

6 days ago talkbio0Tagged Advisory Committees, Clinical Trials, drug safety, Eye, Multiple Myeloma, ODAC, SmithKline Beecham, Toxicity aspects, United States Food and Drug Administration, vote

FDA Advisory Committee; Blenrep; GSK; multiple myeloma; ODAC vote; drug safety; ocular toxicity; clinical trials

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

1 month 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 Splits Votes on Genentech and J&J Cancer Drugs

2 months ago talkbio0Tagged Advisory Committees, applicability, cancer drugs, Clinical Trials, Columvi, genentech, J&J, ODAC, STARGLO, United States Food and Drug Administration, Voting

FDA; advisory committee; Genentech; J&J; cancer drugs; Columvi; ODAC; clinical trials; diffuse large B-cell lymphoma; applicability; STARGLO; voting