Organic Chemical – Page 3

AbbVie’s Rinvoq Achieves Second Phase 3 Win in Alopecia Areata Trials

3 weeks ago talkbio0Tagged AbbVie, Alopecia, Eyebrow structure, Eyelash, hair regrowth, Rinvoq, safety profile, Salts, Score, upadacitinib

AbbVie; Rinvoq; upadacitinib; alopecia areata; Phase 3 clinical trial; hair regrowth; SALT score; eyebrows; eyelashes; safety profile

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

3 weeks 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

Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder

3 weeks ago talkbio0Tagged Clinical Trials, Evidence, Federal Appeals Court, Hetlioz, jet lag disorder, New Drug Application, regulatory law, sNDA, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence

FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

3 weeks ago talkbio0Tagged Analgesics, Non-Narcotic, Approved, Chronic pain, Clinical Trials, cyclobenzaprine, Fibromyalgia, Hairy Cell Leukemia, Phase 3, sublingual tablets, Tonix, Tonmya, United States Food and Drug Administration

Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials

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

4 weeks 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

4 weeks 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

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

4 weeks 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

PureTech Spins Out Celea Therapeutics to Advance IPF Drug Candidate

4 weeks ago talkbio0Tagged Celea Therapeutics, Idiopathic Pulmonary Fibrosis, Lung diseases, LYT 100, Phase 3 trial, pirfenidone, Pulmonary Fibrosis, PureTech, spin-out

PureTech; Celea Therapeutics; spin-out; lung disease; idiopathic pulmonary fibrosis; IPF; deupirfenidone; LYT-100; Sven Dethlefs; phase 3 trial

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

4 weeks 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

Novartis plans global filings after ianalumab hits primary endpoints in two Phase 3 Sjögren’s disease trials

1 month ago talkbio0Tagged B-cell depletion, BAFF‑R, cellular targeting, ESSDAI, ianalumab, NEPTUNUS-1, NEPTUNUS-2, Novartis, Phase 3, regulatory filings, safety profile, Sjögren 's disease

Novartis; ianalumab; BAFF‑R; B-cell depletion; Sjögren’s disease; NEPTUNUS-1; NEPTUNUS-2; ESSDAI; Phase 3; regulatory filings; first targeted treatment; safety profile