On Wednesday, the FDA granted accelerated approval for Gilead Sciences, Inc.’s (NASDAQ:GILD) Livdelzi (seladelpar) for 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. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis. Also Read: Analysts Cite Improved Investor Sentiment For Gilead, But Warn of Limited Growth at Current Stock Levels. The accelerated approval was based primarily on pivotal placebo-controlled Phase 3 RESPONSE study data. In the study, 62% of participants taking Livdelzi achieved the primary endpoint of composite ...