Biologically Active Substance – Page 7

Stealth BioTherapeutics Resubmits Third FDA Application for Rare Disease Drug

3 months 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

3 months 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

3 months 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

3 months 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

3 months 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

3 months 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

3 months 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

Novartis antibody ianalumab clinches another Phase 3 win in rare blood disease (ITP)

3 months ago talkbio0Tagged Autoimmune, Autoimmune thrombocytopenia, B-cell depletion, ianalumab, Infrequent, Inosine Triphosphate, Novartis, Phase 3, platelet levels, Psychological inhibition, regulatory submissions, Sjögren 's disease, TNFRSF13C protein, human, treatment failure, VAY736

Novartis; ianalumab; VAY736; primary immune thrombocytopenia; ITP; rare disease; Phase 3; time to treatment failure; safe platelet levels; eltrombopag; autoimmune; B-cell depletion; BAFF-R inhibition; Sjögren’s disease; regulatory submissions

Bayer-allied NextRNA Therapeutics winds down operations after missing a milestone in their collaboration

3 months ago talkbio0Tagged Bayer, Dana-Farber, Funding, Long Intergenic Non-Protein Coding RNA, Massachusetts biotech, missed milestone, Neoplasms, NextRNA, Series, shutdowns

NextRNA Therapeutics; Bayer; lncRNA; long non-coding RNA; oncology; biotech wind-down; missed milestone; Massachusetts biotech; seed and Series A funding; Dana-Farber; Carl Novina; 2025 biotech shutdowns

Endpoints 11: Biopharma’s most promising startups revealed live in Boston this September

3 months ago talkbio0Tagged Aves, Biopharma, biotech startups, biotechs, Boston event, Endpoints, GALA peptide, Industry, Rating (action), real-time, State Room

Endpoints 11; biotech startups; biopharma; Boston event; State Room; awards gala; early bird rate; industry insiders; 2025 most promising biotechs; real-time reveal