Category Regulatory

Bayer

Bayer and Vanderbilt University Medical Center Collaborate to Advance Therapies for Cardiovascular and Kidney Diseases

Bayer and Vanderbilt University Medical Center Collaborate to Advance Therapies for Cardiovascular and Kidney Diseases  Bayer and Vanderbilt University Medical Center (VUMC) today announced that they have entered a strategic five-year collaboration agreement to advance innovative therapies from target identification…

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ENHERTU

ENHERTU® + Pertuzumab Validated in EU for First-Line HER2+ Metastatic Breast Cancer

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®…

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Celltrion Unveils Drug Pipeline and U.S. Expansion at J.P. Morgan Conference

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…

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TECVAYLI® Monotherapy Shows Superior Survival vs Standard Care in Early Relapsed, Heavily Pretreated Myeloma

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,…

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Biogen Secures European Commission Approval for High-Dose SPINRAZA® (nusinersen) Regimen in Spinal Muscular Atrophy

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…

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Japan Grants Approval for Exdensur (depemokimab) in Severe Asthma and CRSwNP Patients

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…

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Johnson & Johnson Acquires Halda Therapeutics to Advance Next-Gen Oral Cancer Therapies

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…

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Novo Nordisk’s Wegovy® Becomes First Oral GLP-1 Approved in the U.S. for Weight Management

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…

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EC Approves TREMFYA® for Pediatric Plaque Psoriasis — First IL-23 Inhibitor for Children

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…

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Johnson & Johnson Supports HRS Registry to Enhance Real-World Evidence in Pulsed Field Ablation (PFA)

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…

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Johnson & Johnson Secures FDA Approval for TRUFILL n-BCA Liquid Embolic System to Treat Symptomatic Chronic Subdural Hematoma

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…

Read MoreJohnson & Johnson Secures FDA Approval for TRUFILL n-BCA Liquid Embolic System to Treat Symptomatic Chronic Subdural Hematoma