Biologically Active Substance

AbbVie’s Rinvoq Achieves Strong Phase 3 Results in Alopecia Areata, Clearing Key Efficacy Milestone

1 day ago talkbio0Tagged AbbVie, Alopecia, hair regrowth, Inhibitor, Janus kinase, Rinvoq, Salts, Score, upadacitinib

AbbVie; Rinvoq; Phase 3 trial; alopecia areata; hair regrowth; upadacitinib; SALT score; JAK inhibitor

FDA Rejects PTC’s Vatiquinone Application for Friedreich’s Ataxia, Requests Further Studies

3 days ago talkbio0Tagged Clinical Research, Complete Response Letter, drug efficacy, factor IX, Friedreich 's ataxia, Rejection, United States Food and Drug Administration, vatiquinone

FDA rejection; PTC Therapeutics; vatiquinone; Friedreich’s ataxia; complete response letter; drug efficacy; additional clinical studies

FDA Rejection Derails PTC Therapeutics’ Rare Disease Hopeful

3 days ago talkbio0Tagged Clinical Trials, concerns, Effectiveness, factor IX, Failure (biologic function), Friedreich 's ataxia, Rare Diseases, Rejection, Response process, United States Food and Drug Administration, vatiquinone

PTC Therapeutics; FDA rejection; vatiquinone; Friedreich’s ataxia; rare disease; efficacy concerns; complete response letter; clinical trial failure

Stealth BioTherapeutics Resubmits Third FDA Application for Rare Disease Drug

4 days 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

FDA Grants Wegovy 3rd Indication: First GLP-1 Approved for MASH with Moderate-to-Advanced Liver Scarring

5 days ago talkbio0Tagged Accelerated, Approved, Fibrosis, Liver, MASH, noncirrhotic, Nordisk, Product containing glucagon-like peptide 1 receptor agonist (product), semaglutide, United States Food and Drug Administration, Wegovy

Wegovy; FDA approval; MASH; semaglutide; GLP-1 receptor agonist; liver fibrosis; Novo Nordisk; ESSENCE trial; noncirrhotic; accelerated approval

Schrödinger Halts SGR-2921 Leukaemia Programme After Two Deaths

1 week ago talkbio0Tagged CDC7 protein, human, clinical trial halt, drug safety, Inhibitor, leukemia, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, patient deaths, Schrödinger, SGR-2921

Schrödinger; SGR-2921; leukaemia; acute myeloid leukaemia (AML); myelodysplastic syndromes (MDS); CDC7 inhibitor; clinical trial halt; patient deaths; drug safety

Response Pharma: RDX-002 Limits Weight Regain After GLP-1 Therapy – Positive Phase II Results Announced

1 week ago talkbio0Tagged cardiometabolic health, Discontinuation (procedure), Glucagon-Like Peptide 1, iMTP, Inhibitor, Obesity, Phase 2 Clinical Trials, postprandial, RDX-002, Response process, Triglycerides, weight regain

Response Pharmaceuticals; RDX-002; GLP-1 discontinuation; weight regain; obesity; Phase II clinical trial; postprandial triglycerides; cardiometabolic health; iMTP inhibitor

Insmed Secures FDA Approval for First DPP1 Inhibitor in Lung Disease

1 week ago talkbio0Tagged Approved, brensocatib, Brinsupri, Bronchiectasis, CTSC gene, Inhibitor, Insmed, Lung diseases, United States Food and Drug Administration

Insmed; FDA approval; DPP1 inhibitor; Brensocatib; Brinsupri; bronchiectasis; lung disease

AbbVie Invests $195 Million in New North Chicago API Manufacturing Site

1 week ago talkbio0Tagged AbbVie, alpha 1-antitrypsin, domestic production, expansion, Facility (object), Illinois (geographic location), Investments, Manufacturing, North Chicago, pharmaceutical manufacturing

AbbVie; North Chicago; API manufacturing; $195 million investment; facility expansion; pharmaceutical manufacturing; Illinois; domestic production

Insmed’s Brinsupri Receives First-Ever FDA Approval for Progressive Lung Disease

1 week ago talkbio0Tagged Approved, brensocatib, Brinsupri, Bronchiectasis, CTSC gene, Inhibitor, Insmed, Lung diseases, neutrophil-mediated disease, non-cystic fibrosis bronchiectasis, Progressive, United States Food and Drug Administration

Brinsupri; Insmed; FDA approval; non-cystic fibrosis bronchiectasis; bronchiectasis; DPP1 inhibitor; brensocatib; progressive lung disease; neutrophil-mediated disease; first-in-class