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News about "Primary Biliary Cholangitis "
US FDA Grants Priority Review to Zydus Therapeutics' Saroglitazar for Primary Biliary Cholangitis
Zydus Therapeutics has received US FDA Priority Review (PR) for its New Drug Application (NDA) for saroglitazar in the treatment of Primary Biliary Cholangitis (PBC), supported by phase 3 EPICS-III trial results demonstrating significant biochemical response, with detailed data to be presented at the EASL Congress 2026.
Primary Biliary Cholangitis | 29/05/2026 | By News Bureau
GSK Secures FDA Approval for Lynavoy, First Treatment for PBC-Related Chronic Itch
FDA approves GSK’s Lynavoy (linerixibat), the first therapy for cholestatic pruritus in primary biliary cholangitis patients, offering significant and sustained itch relief.
Primary Biliary Cholangitis | 21/03/2026 | By News Bureau | 121
GSK's Linerixibat Granted Priority Review in China for Cholestatic Pruritus in PBC
China’s drug regulator has accepted GSK’s linerixibat for priority review to treat cholestatic pruritus in primary biliary cholangitis, supported by Phase III data showing significant and sustained itch relief.
Primary Biliary Cholangitis | 27/02/2026 | By News Bureau | 173
PANTHERx Rare Collaborates with Gilead Sciences for Distribution of LIVDELZI
LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Primary Biliary Cholangitis | 17/08/2024 | By Aishwarya | 314
Zydus Completes Enrolment for EPICS IIITM Phase 2b/3 Trial of Saroglitazar Mg
Zydus Lifesciences has completed enrolment of Phase 2b/3 EPICS IIITM trial of Saroglitazar Mg in patients with Primary Biliary Cholangitis (PBC).
Primary Biliary Cholangitis | 10/05/2024 | By Aishwarya | 538
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