Drug Approval – Talk Bio

Stealth BioTherapeutics Resubmits Third FDA Application for Rare Disease Drug

2 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, access program, Drug Approval, Elamipretide, Infrequent, resubmission, Stealth BioTherapeutics, United States Food and Drug Administration

Stealth BioTherapeutics; FDA resubmission; rare disease; Barth syndrome; elamipretide; drug approval; expanded access program

Scientists Protest FDA’s Rejection of Replimune’s Tumor Destroying Therapy

4 weeks ago talkbio0Tagged Clinical Trials, Drug Approval, Heterogeneity, IGYNTE, melanoma, Oncolytic Immunotherapy, Rejection, Replimune, RETINITIS PIGMENTOSA 1, scientist protest, United States Food and Drug Administration

Replimune; RP1; FDA rejection; oncolytic immunotherapy; melanoma; clinical trial; IGYNTE study; scientist protest; drug approval; patient heterogeneity

Vinay Prasad Departs FDA Amid Conservative Criticism and Sarepta Gene Therapy Controversy

1 month ago talkbio0Tagged CBER, conservative criticism, departure - ActRelationshipType, Drug Approval, gene therapy, Muscular Dystrophy, Duchenne, Prasad, Transplant Registry Unified Management Program, United States Food and Drug Administration, Vinay

Vinay Prasad; FDA; departure; Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; conservative criticism; CBER; drug approval controversy; Trump administration

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

2 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

2 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