Complete – Talk Bio

Fortress Biotech and Sentynl Therapeutics Fail to Secure FDA Approval for CUTX-101 in Rare Pediatric Menkes Disease

1 month ago talkbio0Tagged biotech, Complete, CUTX-101, deficiencies, Drug Approval, Fortress, Infrequent, Manufacturing, Menkes disease, Pediatric Disorder, Sentynl Therapeutics, United States Food and Drug Administration

Fortress Biotech; Sentynl Therapeutics; FDA Complete Response Letter; CUTX-101; Menkes disease; rare pediatric disease; manufacturing deficiencies; drug approval setback

Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

1 month ago talkbio0Tagged Biogen, Candidiasis, Chronic Mucocutaneous, Complete, controls, High dose, Manufacturing, New Drug Application, nusinersen, regulatory, Response Letter, resubmission, Science of Chemistry, Spinal Muscular Atrophy, Spinraza, United States Food and Drug Administration

Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission

FDA Rejects Scholar Rock’s SMA Drug Due to Catalent Indiana Manufacturing Issues

1 month ago talkbio0Tagged apitegromab, Catalent Indiana, Complete, Drug Approval, manufacturing issues, Response Letter, Scholar Rock, SMA, Spinal Muscular Atrophy, United States Food and Drug Administration

FDA; Scholar Rock; Apitegromab; SMA; Spinal Muscular Atrophy; Catalent Indiana; Complete Response Letter; Manufacturing issues; Drug approval

FDA Rejects Lundbeck and Otsuka’s Rexulti for PTSD on Insufficient Efficacy Evidence

1 month ago talkbio0Tagged brexpiprazole, Clinical Trials, Complete, Drug Approval, Lundbeck, Otsuka, Post-Traumatic Stress Disorder, Response Letter, Rexulti, sertraline, sNDA, United States Food and Drug Administration

FDA; Rexulti; Lundbeck; Otsuka; PTSD; brexpiprazole; sertraline; Complete Response Letter; sNDA; clinical trials; drug approval

FDA Releases Second Batch of Complete Response Letters, Moves to Real-Time Public Disclosure

2 months ago talkbio0Tagged Complete, CRLs, Drug Approval, real-time publishing, regulatory disclosure, Response Letters, United States Food and Drug Administration

FDA; Complete Response Letters; CRLs; real-time publishing; drug approvals; transparency; regulatory disclosure

Replimune Awaits FDA Direction After Complete Response Letter for Advanced Melanoma Therapy

3 months ago talkbio0Tagged Accelerated, Advanced Melanoma, Approved, Cancer Therapeutic Procedure, Complete, IGNYTE trial, nivolumab, Replimune, Response Letter, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration, vusolimogene oderparepvec

Replimune; FDA; Complete Response Letter; RP1; vusolimogene oderparepvec; nivolumab; advanced melanoma; cancer treatment; IGNYTE trial; accelerated approval

Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application

3 months 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 months 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

4 months 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 Milestone Pharmaceuticals’ Etripamil Nasal Spray for PSVT

7 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