Tag Archives: Marketing Authorisation Application

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

GlaxoSmithKline: European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat patients with anaemia of chronic kidney disease

Submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase III clinical trial programme, consisting of five trials that all met their co-primary efficacy and safety endpoints EMA file acceptance is the first major regulatory … Read the full press release

GSK and Pfizer owned ViiV Healthcare announced US regulatory submission for STR combining dolutegravir with abacavir and lamivudine for people living with HIV

London, UK, 23-10-2013 — /EuropaWire/ — ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1. This New Drug … Read the full press release