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FDA issues Complete Response Letter to Eli Lilly and Boehringer for empagliflozin to treat type 1 diabetes.

Written by | 25 Mar 2020

The FDA has issued a complete response letter for the supplemental New Drug Application (sNDA) of the investigational medicine empagliflozin 2.5 mg as an adjunct to insulin for… read more.

FDA grants emergency use authorisation for Xpert Xpress SARS-CoV-2 test for coronavirus.- Cepheid

Written by | 25 Mar 2020

Cepheid announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative… read more.

Oncology Venture reports results of FDA meeting for dovitinib as a treatment for renal cell carcinoma.

Written by | 25 Mar 2020

Oncology Venture has had a meeting with the FDA to discuss a potential path to approval for dovitinib used to treat Renal Cell Carcinoma (RCC) (kidney cancer), the… read more.

Global Phase II/III trial of Kevzara in patients hospitalized with severe COVID-19 infection .- Regeneron + Sanofi

Written by | 25 Mar 2020

Regeneron Pharmaceuticals, Inc. and Sanofi announced they have started a clinical program evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19 infection . Kevzara is a fully-human monoclonal… read more.

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