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FDA extends review date for belumosudil for the treatment of chronic graft-versus-host disease.- Kadmon Holdings.

Read time: 1 mins
Published:14th Mar 2021
Kadmon Holdings, Inc. announced that the FDA has extended the review period for the New Drug Application (NDA) for belumosudil for the treatment of chronic graft-versus-host disease (cGVHD). In a notice received from the FDA on March 9, 2021, the Company was informed that the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of belumosudil 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 submission of the additional information has been determined by the FDA to constitute a major amendment to the NDA, resulting in an extension of the PDUFA date by three months.
Condition: Graft-v-Host Disease (GvHD)
Type: drug

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