Tag Archives: Kaivan Khavandi

European Commission Approves GSK’s Nucala as First Monthly Biologic for Uncontrolled Eosinophilic COPD in the EU

(IN BRIEF) GSK announced that the European Commission has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults in the EU with uncontrolled COPD characterised by raised blood eosinophils who are already receiving inhaled triple therapy, making it the … Read the full press release

GSK Receives Japanese Approval for Exdensur as Twice-Yearly Treatment for Severe Asthma and CRSwNP

(IN BRIEF) GSK has secured approval in Japan for Exdensur (depemokimab), the country’s first ultra-long-acting biologic for severe asthma and chronic rhinosinusitis with nasal polyps. Approved by Japan’s Ministry of Health, Labour and Welfare, the therapy delivers sustained disease control … Read the full press release

GSK Secures China Approval for Nucala in Broad COPD Patient Population

(IN BRIEF) GSK has received approval from China’s National Medical Products Administration for Nucala as an add-on maintenance therapy for adults with inadequately controlled COPD and elevated blood eosinophils. Supported by positive MATINEE and METREX phase III trial data, the … Read the full press release

GSK Acquires Global License for Empirico’s Phase I siRNA Candidate EMP-012 Targeting Novel Inflammatory Pathway in COPD

(IN BRIEF) GSK has signed an exclusive global licensing agreement with Empirico Inc. for EMP-012, a first-in-class siRNA candidate currently in Phase I trials for chronic obstructive pulmonary disease (COPD). EMP-012 targets a distinct inflammatory pathway, offering potential therapeutic benefit … Read the full press release

GSK Submits Linerixibat for European Approval to Treat Debilitating PBC Pruritus

(IN BRIEF) GSK’s marketing authorisation application for linerixibat, an investigational ileal bile acid transporter inhibitor, has been accepted for review by the European Medicines Agency. The submission is supported by GLISTEN Phase III trial data showing that linerixibat rapidly and … Read the full press release

GSK Reports Promising Phase III Findings for Depemokimab in Treating Chronic Rhinosinusitis with Nasal Polyps

(IN BRIEF) GSK plc has announced positive results from its Phase III ANCHOR trials for depemokimab, a biologic treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). The trials demonstrated a significant reduction in nasal polyp size and nasal obstruction after … Read the full press release