(elafibranor) recommended for the treatment of primary biliary cholangitis, following FDA approval in June 2024 CHMP positive opinion for
The FDA on Monday granted accelerated approval to Ipsen and Genfit's elafibranor, now to carry the brand name Iqirvo, for the treatment of the
Ipsen announced that the European Commission has conditionally approved Iqirvo (elafibranor) The FDA declined to approve Vanda's New Drug
Ipsen, Genfit's elafibranor wins FDA approval for primary biliary cholangitis Ipsen and Genfit's elafibranor will now be marketed as Iqirvo and is the first
FDA Approves Elafibranor for Primary Biliary Cholangitis The FDA granted accelerated approval for elafibranor (Iqirvo, Ipsen), a peroxisome proliferator−
FDA Approvals Analyst Ratings Insider Trading SEC filings Market elafibranor in Primary Biliary Cholangitis (PBC) Investigational
On J, the U.S. Food and Drug Administration (FDA) approved Iqirvo (elafibranor - Ipsen).
GENFIT: Ipsen's Iqirvo (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA
elafibranor is an approved drug (FDA (2024)). Compound class: Synthetic FDA approval for this indication in June 2024. Clinical Trials. Clinical
Comments
What the hell would the FDA have to do with it? This is a piece of machinery. They would have NO say about it whatsoever.
Good story - would like to see more!
Do you realize the world doesn't end at USA borders?