About CTEXLI™ (chenodiol ... the Phase 3 EXPAND study, a label expansion opportunity for LIVMARLI in additional settings of cholestatic pruritus. CHOLBAM is FDA-approved for the treatment ...
Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA on ...
The Food and Drug Administration (FDA ... participants received chenodiol 250mg 3 times daily in both open-label periods. Findings showed the estimated mean change from baseline for plasma ...
After asset purchase from Travere, Mirum's Ctexli crosses FDA finish line in rare metabolic disorder
The FDA on Friday gave the green light to Mirum ... s Travere deal—CTX patients have been able to access chenodiol off-label for years. The medication won an orphan drug designation for ...
today announced that the U.S. Food and Drug Administration (FDA) has approved CTEXLI™ (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous xanthomatosis (CTX).
CTEXLI is the first and only medication approved for the treatment of CTX in adults Approval based on Phase 3 RESTORE study results CTEXLI granted U.S. FDA Orphan Drug exclusivity for the ...
today announced that the U.S. Food and Drug Administration (FDA) has approved CTEXLI™ (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous xanthomatosis (CTX). CTEXLI is ...
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