Gilead Seladelpar gets Conditional European Marketing Authorization for Primary Biliary Cholangitis Ruchika Sharma23 Feb 2025 11:30 AM ISTFoster City: Gilead Sciences, Inc. has received conditional marketing authorization from the European Commission (EC) for Seladelpar for the treatment...
FDA Issues Urgent Safety Warning on Ocaliva, Highlights Risk of Serious Liver Injury in Primary Biliary Cholangitis Patients Medha Baranwal15 Dec 2024 8:45 PM ISTUSA: The U.S. Food and Drug Administration (FDA) has issued an important update to its Drug Safety Communication regarding Ocaliva (obeticholic acid),...
Gilead Sciences Seladelpar gets positive CHMP opinion for Primary Biliary Cholangitis Ruchika Sharma15 Dec 2024 12:00 PM ISTFoster City: Gilead Sciences, Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...
US FDA staff questions confirmatory trial data for Intercept's liver disease drug MD Bureau Team13 Sept 2024 3:14 PM ISTLondon: Staff reviewers at the U.S. Food and Drug Administration said on Wednesday a confirmatory trial did not show the effectiveness of Intercept's...
USFDA grants accelerated approval to Gilead Sciences Livdelzi for Primary Biliary Cholangitis Ruchika Sharma17 Aug 2024 3:30 PM ISTFoster City: Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi...
Zydus Lifesciences completes enrolment for EPICS III Phase 2b/3 trial evaluating Saroglitazar Mg for Primary Biliary Cholangitis Ruchika Sharma10 May 2024 11:56 AM ISTSaroglitazar Mg is a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist.
Zydus Lifesciences aims to launch first new drug in US by early 2026 Ruchika Sharma28 Feb 2024 4:30 PM ISTAhmedabad: India's Zydus Lifesciences is aiming to launch its first new drug in the United States by early 2026, looking to tap into the...
High Total Cholesterol in Primary Biliary Cholangitis cases tied to poor clinical outcomes Aditi22 Feb 2024 3:30 AM ISTPatients with primary biliary cholangitis (PBC) often have hypercholesterolemia. However, its association with prognosis and lipid metabolism remains...
Gilead Sciences to acquire CymaBay Therapeutics for USD 4.3 billion Ruchika Sharma13 Feb 2024 12:30 PM ISTFoster City: Gilead Sciences, Inc. and CymaBay Therapeutics, Inc. have announced a definitive agreement under which Gilead will acquire CymaBay...
Seladelpar Improves Pruritus in Patients with Primary Biliary Cholangitis by reducing IL-31, shows trial Medha Baranwal9 Jan 2024 5:30 PM ISTUSA: Newly released data from a post-hoc analysis of the Phase 3 ENHANCE study has demonstrated the impact of seladelpar on serum interleukin-31...
Elafibranor Outperforms Placebo in Improving Biochemical Indicators of Cholestasis: NEJM Aditi22 Nov 2023 9:30 AM ISTPatients with primary biliary cholangitis who don't respond to standard therapy have a high risk of cirrhosis and poor quality of life. Previous...
Seladelpar significantly improves liver biochemistry and pruritus in patients with primary biliary cholangitis Dr. Shravani Dali29 Aug 2023 8:00 PM ISTSeladelpar significantly improves liver biochemistry and pruritus in patients with primary biliary cholangitis suggests a new study published in the...
