As the management landscape of primary biliary cholangitis (PBC) changes, new second-line options offer effective alternatives for patients who respond inadequately to standard first-line treatment ...

Please provide your email address to receive an email when new articles are posted on . Incomplete responders to obeticholic acid had significant increases from baseline in fibroblast growth factor 19 ...

The approval of ursodeoxycholic acid (UDCA) for primary biliary cholangitis (PBC) in 1997 marked a pivotal turning point in management of the condition, substantially reducing the risk of liver ...

According to the CRL, the FDA is continuing to assess the safety data and is therefore not able to approve the sNDA in its current form. The Food and Drug Administration (FDA) has issued a Complete ...

Biochemical non-response to obeticholic acid as a second-line therapy predicted a heightened risk for clinical events in patients with primary biliary cholangitis (PBC). Although response rates to ...

(RTTNews) - Intercept Pharmaceuticals, Inc. (ICPT) announced that REVERSE, a phase 3 study evaluating the safety and efficacy of Obeticholic Acid in patients with compensated cirrhosis due to ...

NEW YORK, May 25, 2017 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat ...

The FDA declined to grant full approval to obeticholic acid (Ocaliva) for treating primary biliary cholangitis (PBC), Intercept Pharmaceuticals announced on Tuesday. The decision follows a September ...

Intercept Pharmaceuticals Inc ICPT announced initial results from a planned interim analysis of its ongoing Phase 2 study 747-213, an active comparator trial demonstrating the therapeutic potential of ...

Company to discontinue all NASH-related investment and restructure the Company’s operations to strengthen its focus on rare and serious liver diseases Company anticipates achieving profitability in ...

Please provide your email address to receive an email when new articles are posted on . Patients who received obeticholic acid for primary biliary cholangitis experienced greater transplant-free ...

Credit: Getty Images. A regulatory decision is expected on June 22, 2023. The Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee voted 12 “no” and 2 “yes” (with 2 ...