Blenrep – Talk Bio

FDA Delays Blenrep Decision, Challenging GSK’s Multiple Myeloma Comeback Plans

3 months ago talkbio0Tagged Blenrep, Deferred, Multiple Myeloma, Neoplasms, Ocular Toxicity, PDUFA, regulatory hurdles, SmithKline Beecham, United States Food and Drug Administration

FDA delay; Blenrep; GSK; multiple myeloma; regulatory hurdles; ocular toxicity; PDUFA; oncology; relapsed/refractory

FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

3 months ago talkbio0Tagged Advisory Panel, Blenrep, concerns, DREAMM, Drug Approval, Multiple Myeloma, Ocular Toxicity, Refractory Plasma Cell Myeloma, Relapsing course, Safety, SmithKline Beecham, trials, United States Food and Drug Administration

Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma

FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return

3 months ago talkbio0Tagged Advisory Committees, Blenrep, Drug Approval, Eye, Eye safety, Multiple Myeloma, relapsed/refractory multiple myeloma, SmithKline Beecham, Toxicity aspects, United States, United States Food and Drug Administration

GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma