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GSK and Vir Biotechnology Announce the Start of the EMA Rolling Review of VIR-7831 .
Vir Biotechnology, Inc.May 7, 2021 GMT
– Rolling review will evaluate sotrovimab in adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19 –
– Review will support a formal Marketing Authorization Application –
– GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19 –
LONDON and SAN FRANCISCO, May 07, 2021 (GLOBE NEWSWIRE) GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and o
ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV
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ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV
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