---
title: "Gilead Sciences' Livdelzi Receives Accelerated Approval from U.S. FDA and Conditional Approval from UK MHRA, Regulatory Reviews Underway in Canada and Australia"
description: "Gilead Sciences Inc. announced that Livdelzi® (seladelpar) has received accelerated approval from the U.S. FDA and conditional approval from the UK MHRA for treating primary biliary cholangitis (PBC)."
type: "news"
locale: "en"
url: "https://longbridge.com/en/news/239050012.md"
published_at: "2025-05-07T06:25:59.000Z"
---

# Gilead Sciences' Livdelzi Receives Accelerated Approval from U.S. FDA and Conditional Approval from UK MHRA, Regulatory Reviews Underway in Canada and Australia

> Gilead Sciences Inc. announced that Livdelzi® (seladelpar) has received accelerated approval from the U.S. FDA and conditional approval from the UK MHRA for treating primary biliary cholangitis (PBC). The drug also received conditional marketing authorization in the EU, with regulatory reviews ongoing in Canada and Australia, marking a significant advancement in accessibility for PBC patients.

Gilead Sciences Inc. has announced that Livdelzi® (seladelpar), known as Lyvdelzi® in the European Union, has received conditional marketing authorization in the EU for the treatment of primary biliary cholangitis (PBC). Additionally, Livdelzi was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2024 and conditional approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in January 2025. The regulatory review process is also underway in Canada and Australia, reflecting a significant step forward in making Livdelzi accessible to individuals with PBC across various regions. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Gilead Sciences Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250506771103) on May 07, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)

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> **Disclaimer**: This article is for reference only and does not constitute any investment advice.