Qualitative Concept – Page 5

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

4 weeks 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

4 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

4 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

Schrödinger Halts SGR-2921 Leukaemia Programme After Two Deaths

4 weeks 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

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

1 month 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

1 month 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

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

1 month ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

AbbVie and Genmab Move to Expand Use of T Cell Engager Epkinly Following Strong Phase III Results

1 month ago talkbio0Tagged AbbVie, Antibodies, Bispecific, Approved, Epcoritamab, EPKINLY, expansion, Genmab, Labels (device), lenalidomide, Lymphoma, Follicular, Phase 3 Clinical Trials, rituximab, T-Cell engager, United States Food and Drug Administration

Epkinly; epcoritamab; AbbVie; Genmab; follicular lymphoma; T cell engager; bispecific antibody; Phase III trial; FDA approval; label expansion; Rituximab; Lenalidomide

FDA Grants Accelerated Approval to Jazz’s Dordaviprone (Modeyso), the First Treatment for Ultra-Rare Brain Tumor

1 month ago talkbio0Tagged Accelerated, Approved, Brain Neoplasms, Chimerix acquisition, Confirmatory Trial, Dordaviprone, midline glioma, Modeyso, pediatric brain cancer, United States Food and Drug Administration

Dordaviprone; Modeyso; FDA approval; H3 K27M-mutant diffuse midline glioma; ultra-rare brain tumor; Jazz Pharmaceuticals; accelerated approval; pediatric brain cancer; Chimerix acquisition; confirmatory trial