ENHERTU® Plus Pertuzumab Moves Closer to EU Approval as First-Line Therapy for HER2-Positive Metastatic Breast Cancer In a significant milestone for oncology innovation, the European Medicines Agency (EMA) has officially validated the Type II Variation marketing authorization application for ENHERTU®…
Celltrion Unveils Innovative Drug Pipeline and Expands U.S. Manufacturing and R&D Strategy at 44th Annual J.P. Morgan Healthcare Conference Celltrion, a leading global biopharmaceutical company, today presented key strategic priorities and clinical development updates for its innovative drug pipelines including…
TECVAYLI® Monotherapy Shows Superior Survival vs. Standard Care in Early Relapsed, Heavily Pretreated Multiple Myeloma Johnson & Johnson, a worldwide leader in multiple myeloma therapies, today announced positive topline results from the investigational Phase 3 MajesTEC-9 study of TECVAYLI® (teclistamab-cqyv) monotherapy,…
Biogen Secures European Commission Approval for High-Dose SPINRAZA® (nusinersen) Regimen in Spinal Muscular Atrophy Biogen Inc. today announced the European Commission (EC) has granted marketing authorization for a high dose regimen of SPINRAZA® (nusinersen) which is comprised of 50 mg/5 mL…
NVIDIA and Lilly Launch Joint AI Lab to Transform Drug Discovery in the AI Era NVIDIA and Eli Lilly and Company today announced a first-of-its-kind AI co-innovation lab focused on applying AI to tackle some of the most enduring challenges…
Japan Approves Exdensur (depemokimab) for Severe Asthma and Nasal Polyps GSK plc has announced that Japan’s Ministry of Health, Labour and Welfare has approved Exdensur (depemokimab) for the treatment of bronchial asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The…
Johnson & Johnson Acquires Halda Therapeutics, Gaining Innovative Platform to Transform Cancer Treatment and Advance Next-Generation Oral Therapies Johnson & Johnson today announced the successful completion of its acquisition of Halda Therapeutics OpCo, Inc. (“Halda”), a clinical-stage biotechnology company with a…
Novo Nordisk’s Wegovy® Becomes First Oral GLP-1 Therapy Approved in the U.S. for Weight Management Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Wegovy® pill (once-daily oral semaglutide 25 mg) to reduce excess body…
EC approves TREMFYA® for pediatric plaque psoriasis — first IL-23 inhibitor for children Johnson & Johnson today announced that the European Commission (EC) has extended the marketing authorisation for TREMFYA® (guselkumab) as a subcutaneous treatment to treat moderate to severe Pediatric plaque…
Johnson & Johnson Supports HRS Registry to Enhance Real-World Evidence for PFA ohnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced its sponsorship of a new data collection platform developed by the Heart Rhythm Society (HRS) to…
Johnson & Johnson Secures FDA Approval for TRUFILL n-BCA Liquid Embolic System to Treat Symptomatic Chronic Subdural Hematoma Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication…
Novo Nordisk Submits FDA Application for CagriSema—First Once-Weekly Combination of GLP-1 and Amylin Analogues for Weight Management Today, Novo Nordisk announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-weekly CagriSema…