Ipsen Confirms U.S. FDA Grants Priority Review for New Drug Application for Elafibranor for the Treatment of Rare Cholestatic Liver Disease, PBC
New Drug Application granted priority review with PDUFA date set for June 10, 2024
European Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor
Investigational elafibranor is the first novel...
Source: Drugs.com - New Drug Applications - Category: Drugs & Pharmacology Source Type: news
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