Posted by Michael Wonder on 18 Aug 2023
FDA grants priority review for full approval of Tarpeyo for the treatment of IgA nephropathy
18 August 2023 - Calliditas Therapeutics today announced that the US FDA has accepted the submission for the supplemental new drug application for Tarpeyo (budesonide) delayed release capsules and granted priority review.
The PDUFA goal date is 20 December 2023.
