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NICE (UK) positive for Iqirvo (elafibranor) for previously treated primary biliary cholangitis when used with UDCA; or alone, if UDCA cannot be tolerated – Ipsen

Written by | 21 Jul 2025

NICE (UK): 1.1 Elafibranor is recommended, within its marketing authorisation, as an option for treating primary biliary cholangitis in adults, when used: i) with ursodeoxycholic acid (UDCA), if… read more.

Seladelpar demonstrated a sustained and consistent long term efficacy and safety profile in primary biliary cholangitis – Gilead Sciences

Written by | 6 Jun 2025

Gilead Sciences, Inc., following the recent acquisition of CymaBay Therapeutics, Inc., announced two-year interim results from the ongoing ASSURE study of investigational seladelpar for the treatment of primary… read more.

Seladelpar granted conditional European Marketing Authorization for the treatment of primary biliary cholangitis – Gilead Sciences

Written by | 6 Mar 2025

Gilead Sciences Inc. announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic… read more.

CHMP positive for seladelpar for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid – Gilead Sciences

Written by | 25 Feb 2025

Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending seladelpar for the… read more.

MHRA (UK) approves seladelpar (Livdelzi) to treat primary biliary cholangitis – CymaBay

Written by | 12 Feb 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) (UK) has  16 January 2025, approved the medicine seladelpar (Livdelzi) in adults for the treatment of a liver illness called… read more.

Late breaking data for Iqirvo (elafibranor) from interim analysis of Phase III ELATIVE study for Primary Biliary Cholangitis at AASLD meeting – Ipsen

Written by | 20 Nov 2024

Ipsen announced  late-breaking data for Iqirvo (elafibranor 80 mg tablets) from an interim analysis of the ongoing open-label extension of the Phase III ELATIVE study at the American… read more.

Iqirvo (elafibranor) receives FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis – Ipsen

Written by | 24 Jun 2024

Ipsen announced that the FDA has granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid… read more.

Intercept Pharmaceuticals Inc. announces updates to Ocaliva prescribing information for primary biliary cholangitis

Written by | 29 May 2021

Intercept Pharmaceuticals, Inc. announced that the Ocaliva (obeticholic acid or OCA) Prescribing Information in the United States has been updated.The changes to the Ocaliva Prescribing Information were prompted… read more.

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