Genfit: filing for elafibranor accepted by the FDA
'The investigational once-daily oral drug could become the first new second-line treatment for primary biliary cholangitis, a rare cholestatic liver disease, in nearly a decade', they point out.
The European Medicines Agency has also approved elafibranor's marketing authorization application. In addition, a third application for regulatory approval has been validated for review by the MHRA in the UK.
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