seladelpar Date Designated: Orphan Designation: Treatment of primary biliary cholangitis Orphan Designation Status: Designated FDA Orphan Approval Status: Not FDA Approved for Orphan Indication Sponsor:
Seladelpar (Livdelzi; Gilead Sciences Inc) was granted accelerated approval by the FDA for the treatment of primary biliary cholangitis (PBC) in
Seladelpar is a peroxisome proliferator-activated receptor (PPAR)-delta ( ) agonist. Seladelpar is a single enantiomer of the R-configuration. 5 On Aug, seladelpar was granted accelerated approval by the FDA for the treatment of primary biliary cholangitis, 6 which is a
Approval FDA Grants Accelerated Approval for Livdelzi (seladelpar) for the Treatment of Primary Biliary Cholangitis: : Gilead s Seladelpar Demonstrated a Sustained and Consistent Long-Term Efficacy and Safety Profile in Primary Biliary Cholangitis:
Seladelpar (Livdelzi) has received accelerated approval from the FDA for the treatment of primary biliary cholangitis (PBC).
The FDA has granted accelerated approval to Livdelzi (seladelpar), Gilead's treatment for primary biliary cholangitis (PBC) in adults who
U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC)
The U.S. Food and Drug Administration (FDA) has approved Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC), an autoimmune
Gilead's Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA – Livdelzi Expands Gilead's Long-
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