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FDA Accepts GSK's NDA for Linerixibat in Rare Disease-Related ItchLinerixibat NDA Based on GSK's GLISTEN Study The NDA for linerixibat was based on data from the phase III GLISTEN study. In November 2024, the company announced positive data from the study.
The FDA has accepted for review the NDA for linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.
GSK's marketing application for linerixibat, targeting cholestatic pruritus in PBC patients, gains EMA acceptance based on phase III success.
The EMA has started a review of GSK's treatment candidate for primary biliary cholangitis (PBC), linerixibat, offering hope to patients of an effective treatment for the relentless itching caused ...
GSK reveals the data behind its linerixibat for itching associated with autoimmune liver disease PBC as it anticipates first approvals for the drug ...
(RTTNews) - GSK plc (GSK), Monday confirmed that the European Medicines Agency has accepted its marketing authorisation application for linerixibat, an investigational ileal bile acid transporter ...
Linerixibat GLISTEN pIII trial data at EASL | Regulatory News· Primary and key secondary endpoints met, demonstrating a rapid, significant and sustained improvement in cholestatic pruritus and ...
While linerixibat is not yet approved for use, it has received orphan drug designation from the US Food and Drug Administration and the European Medicines Agency for the treatment of cholestatic ...
GSK's marketing application for linerixibat, targeting cholestatic pruritus in PBC patients, gains EMA acceptance based on phase III success.
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