United States Food and Drug Administration
Novartis Intensifies Entresto Defense with FDA Complaint Amid Patent Lawsuits
Novartis, Entresto, FDA complaint, patent lawsuits, pharmaceuticals
GSK Secures Broad Label Expansion for Jemperli in First-Line Endometrial Cancer
GSK, Jemperli, dostarlimab, endometrial cancer, FDA approval, chemotherapy, immuno-oncology, Keytruda, Merck
FDA Approves Tecelra, the First Engineered Cell Therapy for Solid Tumors, to Treat Synovial Sarcoma
Tecelra, Adaptimmune, FDA approval, engineered cell therapy, solid tumor, synovial sarcoma, MAGE-A4 antigen, TCR cell therapy
Adaptimmune Receives FDA Accelerated Approval for T Cell Receptor Cell Therapy in Rare Soft Tissue Cancer
Adaptimmune, FDA approval, T cell receptor cell therapy, synovial sarcoma, rare soft tissue cancer, afamitresgene autoleucel, TECELRA
FDA Approves Broader Label for GSK’s Jemperli in First-Line Endometrial Cancer
FDA, GSK, Jemperli, dostarlimab-gxly, endometrial cancer, chemotherapy, carboplatin, paclitaxel, mismatch repair proficient, microsatellite stable, overall survival, progression-free survival
Novartis Sues FDA Over Approval of Entresto Generic After Petition Rejection
Novartis, FDA, Entresto, generic drug, lawsuit, patent exclusivity, heart failure medication
FDA Approves Johnson & Johnson’s New Multiple Myeloma Therapy
FDA approval, Johnson & Johnson, multiple myeloma, CAR-T cell therapy, bispecific antibody, TALVEY, CARVYKTI, DARALEXASPRO
FDA Decision on Vertex’s Non-Opioid Analgesic Suzetrigine Due Early Next Year
FDA, Vertex, Suzetrigine, Non-Opioid Analgesic, Acute Pain, PDUFA, Priority Review
FDA Criticizes Brittany Mahomes’ Paid Instagram Post for Kaléo’s Auvi-Q
FDA, Brittany Mahomes, Kaléo, Auvi-Q, misleading advertisement, social media regulation, pharmaceutical marketing
FDA Approves New Oral Alzheimer’s Therapy, Expands Label for Grifols SCIg Therapy
FDA, Alzheimer’s disease, Grifols, XEMBIFY, immunoglobulin, subcutaneous, immunodeficiency, plasma-derived therapeutics