Approved – Talk Bio

Lilly to Seek Global Approval for GLP-1 Pill After Obesity and Diabetes Trial Success

17 hours ago talkbio0Tagged Approved, Clinical Trials, Contraceptives, Oral, Diabetes Mellitus, Non-Insulin-Dependent, Eli, Eli Lilly, Glucagon-Like Peptide 1, Obesity, orforglipron, United States Food and Drug Administration, Weight Loss

Eli Lilly; GLP-1 pill; orforglipron; obesity; type 2 diabetes; FDA approval; weight loss; clinical trial

Akeso, Summit’s PD-1xVEGF Drug Ivonescimab Shows Strong Progression-Free Survival Benefit in Global Lung Cancer Trial

17 hours ago talkbio0Tagged Akeso, Antibodies, Bispecific, Approved, Ivonescimab, Non-Small Cell Lung Carcinoma, Overall Survival, PD-1xVEGF, Phase 3 trial, Progression-Free Survival, summit, United States Food and Drug Administration

Akeso; Summit Therapeutics; ivonescimab; PD-1xVEGF; bispecific antibody; non-small cell lung cancer; progression-free survival; Phase 3 trial; overall survival; FDA approval

Argenx Prepares FDA Filing to Expand Vyvgart Use in Myasthenia Gravis After Late-Stage Trial Win

2 days ago talkbio0Tagged Approved, Argenx, Clinical Trials, Myasthenia Gravis, Myasthenia Gravis, Generalized, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Self-injection, Syringes, United States Food and Drug Administration, Vyvgart

Argenx; Vyvgart; FDA approval; myasthenia gravis; prefilled syringe; self-injection; chronic inflammatory demyelinating polyneuropathy; generalized myasthenia gravis; clinical trial

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

1 week 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

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

1 week 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

FDA Grants Full Approval to Precigen’s Papzimeos for Rare Disease RRP

2 weeks ago talkbio0Tagged Approved, Episodic, gene therapy, Immunotherapy, Infrequent, orphan drug designation, Papzimeos, Precigen, Recurrent respiratory papillomatosis, RRP, United States Food and Drug Administration

Precigen; Papzimeos; FDA approval; recurrent respiratory papillomatosis (RRP); gene therapy; immunotherapy; rare disease; Orphan Drug designation

Precigen Receives FDA Approval for First Immunotherapy for HPV-Related Recurrent Respiratory Papillomatosis

2 weeks ago talkbio0Tagged Adenovirus Vector, Approved, Episodic, gene therapy, human papillomavirus, Identifier, Immunotherapy, Papzimeos, Precigen, Recurrent respiratory papillomatosis, RRP, United States Food and Drug Administration, zopapogene imadenovec-drba

Precigen; FDA approval; Papzimeos; zopapogene imadenovec-drba; HPV; recurrent respiratory papillomatosis (RRP); immunotherapy; gene therapy; adenoviral vector; Breakthrough Therapy designation

Insmed Secures FDA Approval for First DPP1 Inhibitor in Lung Disease

2 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

2 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

Bayer Expands Oncology Pipeline with $1.3B Kumquat Deal

2 weeks ago talkbio0Tagged Approved, Bayer, Cancer Therapeutic Procedure, commercialization, G12D inhibitor, K-ras Oncogene, Kumquat Biosciences, milestone payments, Oncology Pipeline, precision oncology, United States Food and Drug Administration

Bayer; Kumquat Biosciences; oncology pipeline; KRAS G12D inhibitor; FDA approval; cancer therapy; precision oncology; commercialization; milestone payments