October 4th 2024
A review of 5 highly anticipated FDA decisions expected by year-end, including acoramidis for ATTR-CM, olezarsen for FCS, sotagliflozin for T1D and CKD, and more.
FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis
August 14th 2024The accelerated approval is based on phase 3 data demonstrating seladelpar’s impact on ALP reduction and is contingent upon verification and description of clinical benefit in confirmatory trial(s).