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 Raises Outlook After Q2 Beat, Eyes USD 53.44B Sales by 2031 Parthika Patel31 July 2025 10:15 AM ISTBengaluru: British drugmaker GSK expects annual sales and profit to be towards the top of its forecast range, after second-quarter sales and earnings...
NPPA Approves Separate Price for GSK's New Paracetamol-Phenylephrine Sachet Parthika Patel29 July 2025 10:12 PM ISTNew Delhi: The National Pharmaceutical Pricing Authority (NPPA), under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, has...
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...
CDSCO Panel Approves GSK's Proposal to Double Indian Patient Pool in Dostarlimab Trial Parthika Patel15 July 2025 7:34 PM ISTNew Delhi: In a recent regulatory development, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control...
Aurobindo Pharma to manufacture, supply HIV treatment cabotegravir across 133 countries Ruchika Sharma15 July 2025 5:46 PM ISTNew Delhi: Hyderabad-based drugmaker Aurobindo Pharma will produce and supply Cabotegravir, a long-acting injectable HIV treatment, across 133...
