Posted by Michael Wonder on 29 May 2026
Zydus Therapeutics new drug application for saroglitazar to treat primary biliary cholangitis granted priority review by the US FDA
28 May 2026 - Zydus Therapeutics today announced that the US FDA granted priority review to the new drug application for saroglitazar.
The proposed indication is for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
The US FDA has assigned a PDUFA target action date of 27 November 2026.
