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New drug application submission was based on positive data from the Phase III GLISTEN trial, which demonstrated significant ...
London: GSK plc has announced the New Drug Application (NDA) for linerixibat, an investigational targeted inhibitor of the ...
Drugmaker GSK revealed on Monday that a new drug application for its linerixibat asset had been accepted for review by the US ...
Linerixibat, an investigational oral ileal bile acid transporter (IBAT) inhibitor, improved cholestatic pruritus in patients with primary biliary cholangitis (PBC), the randomized phase III ...
Gilead’s Livdelzi Shows Lasting Efficacy in Primary Biliary Cholangitis, Regardless of Prior Therapy
Interim results from the ongoing Phase III ASSURE trial demonstrated that Livdelzi maintained a consistent biochemical response in patients with primary biliary cholangitis. Results from an interim ...
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis ...
Liver disease is on the rise in the United States. Women are at a higher risk of developing a certain type of liver disease ...
US FDA accepts for review GSK’s NDA for linerixibat to treat cholestatic pruritus in patients with PBC: London, UK Tuesday, June 3, 2025, 11:00 Hrs [IST] GSK plc announced the U ...
Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the first dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).
Aramchol treatment leads to significant inhibition (2-fold, p<0.05) of TGFβ-induced hepatic fibrosis pathways while upregulating peroxisome proliferator activated receptor (PPAR) signaling ...
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Zacks Investment Research on MSNFDA Accepts GSK's NDA for Linerixibat in Rare Disease-Related ItchGSK plc GSK announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval of its ...
GSK has reported promising results with a drug to treat the severe itching that plagues patients with rare cholestatic liver disease primary biliary cholangitis (PBC). Interim results from the ...
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