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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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Investegate |GlaxoSmithKline PLC Announcements | GlaxoSmithKline PLC: 1st Quarter Results
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LONDON, April 22, 2021 /PRNewswire/ GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company s Biologics License Application. JEMPERLI is indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).