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