KDMN - FDA extends review period for Kadmon's belumosudil NDA

Kadmon Holdings (KDMN) announces that the U.S. FDA has extended the review period for the New Drug Application ((NDA)) for belumosudil for the treatment of chronic graft-versus-host disease ((cGVHD)). The action date has been extended to August 30, 2021.The FDA extended the PDUFA date to allow time to review additional information submitted by Kadmon in response to a recent FDA information request, the company said.The submission of the additional information has been determined by the health regulator to constitute a major amendment to the NDA, resulting in an extension of the action date by three months.

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FDA extends review period for Kadmon's belumosudil NDA