USFDA extends review period for GSK Blenrep in relapsed/refractory multiple myeloma Ruchika Sharma24 July 2025 1:30 PM ISTLondon: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics License Application...
GSK fails to gain FDA advisers backing for cancer therapy Ruchika Sharma20 July 2025 11:30 AM ISTGSK plc has announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk...
GSK Shingrix approved by USFDA in prefilled syringe presentation Ruchika Sharma17 July 2025 2:19 PM ISTLondon: GSK plc has received approval from the US Food and Drug Administration (FDA) for a prefilled syringe presentation of Shingrix (GSK's...
GSK blood cancer drug Blenrep faces USFDA scrutiny over vision issues Ruchika Sharma16 July 2025 4:15 PM ISTGSK's blood cancer drug, Blenrep, is under the U.S. Food and Drug Administration (USFDA) spotlight, as staff reviewers raised safety concerns on...
GSK application for expanded RSV vaccine Arexvy use for adults 18-49 accepted for review by USFDA Ruchika Sharma15 July 2025 2:30 PM ISTLondon: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend the indication of...
GSK buys efimosfermin alfa from Boston Pharma for USD 2 billion Ruchika Sharma9 July 2025 3:30 PM ISTLondon: GSK plc has concluded the acquisition of efimosfermin alfa from Boston Pharmaceuticals in a USD 2 billion deal.Efimosfermin is a...
Bharat Biotech to cut malaria vaccine RTS.S price to under USD 5 for children in endemic countries Ruchika Sharma25 Jun 2025 2:54 PM ISTHyderabad: Bharat Biotech will be reducing the price of world's first malaria vaccine RTS.S, developed by GSK, PATH and...
GSK application for expanded use of RSV vaccine in adults aged 18-49 accepted in Japan Ruchika Sharma22 Jun 2025 11:30 AM ISTGSK plc has announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has accepted the company's regulatory application to expand the use...
GSK RSV vaccine Arexvy accepted for regulatory review by EMA to expand use in adults 18 years, older Ruchika Sharma15 Jun 2025 10:00 AM ISTLondon: GSK plc has announced that the European Medicines Agency (EMA) has accepted the company's regulatory application to expand the use...
GSK Linerixibat application for cholestatic pruritus in primary biliary cholangitis patients under USFDA review Ruchika Sharma3 Jun 2025 2:15 PM ISTLondon: GSK plc has announced the New Drug Application (NDA) for linerixibat, an investigational targeted inhibitor of the ileal bile...
GSK Blenrep combos receive positive EMA Committee opinion in relapsed/refractory multiple myeloma Ruchika Sharma25 May 2025 1:30 PM ISTGSK plc has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of...
GSK Nucala wins USFDA OK for use in adults with COPD Ruchika Sharma23 May 2025 12:17 PM ISTLondon: GSK plc has received approval from the US Food and Drug Administration (FDA) for Nucala (mepolizumab) as an add-on maintenance treatment for...
