Posted by Michael Wonder on 14 Aug 2021
Ipsen announces withdrawal of palovarotene NDA, confirming intention to resubmit following additional data analyses
13 August 2021 - This follows ongoing dialogue with the U.S. FDA regarding the palovarotene NDA review, initiated in May 2021.
Ipsen today announced, following very recent discussions with the U.S. FDA, withdrawal of the new drug application for palovarotene.
