GSK's Efimosfermin Secures FDA Breakthrough and EMA PRIME Status for MASH Treatment
The dual regulatory designations from US FDA and European Medicines Agency fast-track development of GSK’s investigational liver therapy for metabolic dysfunction-associated steatohepatitis.
GSK Plc | 29/04/2026 | By News Bureau | 110
GSK plc Secures China Approval for Blenrep Combination Therapy in Multiple Myelom
National Medical Products Administration approves Blenrep with bortezomib and dexamethasone for relapsed or refractory patients, backed by strong phase III trial outcomes.
GSK Plc | 21/04/2026 | By News Bureau
GSK plc Secures Japan Orphan Drug Status for Ris-Rez in Small-Cell Lung Cancer
Japan’s health ministry grants orphan drug designation to GSK’s investigational ADC Ris-Rez for SCLC, supported by early clinical data showing durable responses in advanced-stage patients.
GSK Plc | 24/03/2026 | By News Bureau | 130
GSK Secures FDA Approval for Lynavoy, First Treatment for PBC-Related Chronic Itch
FDA approves GSK’s Lynavoy (linerixibat), the first therapy for cholestatic pruritus in primary biliary cholangitis patients, offering significant and sustained itch relief.
GSK Plc | 21/03/2026 | By News Bureau | 121
GSK Reports Real-World Data Showing Strong Effectiveness of RSV Vaccine in Older Adults
New US and Denmark studies presented at ReSViNET 2026 show GSK’s RSV vaccine is associated with reduced hospitalisations and lower risk of severe cardiovascular and respiratory complications in adults aged 60 and above.
GSK Plc | 19/02/2026 | By News Bureau | 158
GSK Wins EU Approval for Exdensur in Severe Asthma and CRSwNP
European Commission clears twice-yearly depemokimab for type 2 inflammation-driven severe asthma and chronic rhinosinusitis with nasal polyps, backed by positive Phase III SWIFT and ANCHOR data.
GSK Plc | 18/02/2026 | By News Bureau | 135
GSK's RSV Vaccine Arexvy Accepted for Regulatory Review in China for Adults Aged 60 and Above
China’s drug regulator has accepted GSK’s Arexvy for review to prevent RSV-related lower respiratory tract disease in adults 60 and older, with a decision expected in 2027.
GSK Plc | 11/02/2026 | By News Bureau | 179
European Commission Expands GSK's RSV Vaccine Arexvy to Adults Aged 18 and Above
GSK’s RSV vaccine Arexvy receives European approval for adults aged 18 plus, marking a major expansion in protection against RSV-related respiratory illness across the region.
GSK Plc | 28/01/2026 | By News Bureau | 140
GSK Completes Acquisition of Efimosfermin from Boston Pharmaceuticals for USD 2 Billion
GSK has completed its acquisition of efimosfermin alfa, a Phase III-ready investigational therapy for serious liver diseases, from Boston Pharmaceuticals in a deal worth up to USD 2 billion.
GSK Plc | 09/07/2025 | By Mrinmoy Dey | 333
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