Keyword: priority review

News

Novartis’ Zykadia Wins FDA Priority Review

27.02.2017 - The US Food and Drug Administration (FDA) has accepted Swiss pharmaceutical major Novartis’ supplemental New Drug Application (sNDA) for filing and granted priority review for the...

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FDA Accepts Sanofi’s Diabetes Drug as NDA

23.02.2016 - The US Food and Drug Administration (FDA) has accepted Sanofi’s New Drug Application (NDA) for the French drugmaker’s investigational fixed-ratio combination of basal insulin...

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Merck-Pfizer Avelumab on FDA Fast Track

08.10.2015 - After previously receiving Orphan Drug status for avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody to treat the rare and aggressive skin cancer Merkel...