Rejection – Talk Bio

Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application

3 days ago talkbio0Tagged Antineoplastic Agents, Clinical Trial Design, Complete, Drops - Drug Form, Frequency of Responses, melanoma, Prices, Rejection, Replimune, Response Letter, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration

Replimune; RP1; FDA rejection; melanoma; cancer drug; Complete Response Letter; clinical trial design; objective response rate; share price drop

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

3 days ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy

FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy

2 weeks ago talkbio0Tagged Capricor Therapeutics, Cardiomyopathies, Cell Therapy, Clinical Data, Complete, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3, Rejection, Response process, United States Food and Drug Administration

FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

2 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay

Applied Therapeutics’ Rare Disease Drug Fails Another Phase 3 Trial After FDA Rejection

2 months ago talkbio0Tagged Aldose Reductase Inhibitor, Apply, Cautionary Warning, Classical galactosemia, clinical trial conduct, Govorestat, Infrequent, Rejection, United States Food and Drug Administration

Applied Therapeutics; govorestat; rare disease; phase 3 failure; FDA rejection; classic galactosemia; aldose reductase inhibitor; clinical trial conduct; FDA warning letter

FDA rejection of extended dosing interval is another piece of bad news for Regenerons Eylea HD

3 months ago talkbio0Tagged Age related macular degeneration, Diabetic Retinopathy, dosing, Extension, Eylea HD, Interval, Regeneron, Rejection, United States Food and Drug Administration

United States Food and Drug Administration, Interval, Regeneron, dosing, Extension, Eylea HD, rejection, Age related macular degeneration, Diabetic Retinopathy

FDA Rejects Milestone Pharmaceuticals’ Etripamil Nasal Spray for PSVT

4 months ago talkbio0Tagged Cardamyst, Complete, etripamil, Milestone, Paroxysmal supraventricular tachycardia, Rejection, Response process, United States Food and Drug Administration

Etripamil, Cardamyst, PSVT, FDA rejection, Complete Response Letter, manufacturing issues, Milestone Pharmaceuticals

FDA Rejects Atara’s Ebvallo Due to Manufacturing Issues, Not Efficacy or Safety Concerns

6 months ago talkbio0Tagged Atara, Ebvallo, Epstein-Barr virus, Laboratory, Pierre, Post-transplant lymphoproliferative disorder, Rejection, T-cell immunotherapy, United States Food and Drug Administration

Atara Therapeutics, Ebvallo, FDA rejection, manufacturing issues, post-transplant lymphoproliferative disease (PTLD), Epstein-Barr virus (EBV), T-cell immunotherapy, Pierre Fabre Laboratories.