GSK Gepotidacin accepted for priority review by USFDA for oral treatment of uncomplicated urogenital gonorrhoea Ruchika Sharma12 Aug 2025 12:49 PM ISTLondon: GSK plc has announced that a supplemental New Drug Application for gepotidacin has been accepted by the US Food and Drug Administration...
CureVac announces resolution of patent litigation with Pfizer/BioNTech Ruchika Sharma8 Aug 2025 5:30 PM ISTCureVac N.V., a multinational biotech company developing a new class of transformative medicines based on messenger RNA (mRNA), has announced that...
GSK, Hengrui Pharma to develop up to 12 medicines across Respiratory, Immunology & Inflammation and Oncology Ruchika Sharma29 July 2025 2:30 PM ISTLondon: GSK plc has announced it has entered into agreements with Hengrui Pharma (600276.SH; 01276.HK) to develop up to 12 innovative medicines,...
GSK Blenrep combos approved in EU for treatment of relapsed/refractory multiple myeloma Ruchika Sharma27 July 2025 11:00 AM ISTLondon: GSK plc has received approval for Blenrep in the European Union (EU) for the treatment of adults with relapsed or refractory...
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...
