Posted by Michael Wonder on 31 Jan 2019
Stemline Therapeutics announces validation of marketing authorisation application by the European Medicines Agency
30 January 2019 - Stemline Therapeutics today announced that the EMA has completed its validation of the marketing authorisation application for Elzonris (tagraxofusp-erzs).
Validation of the marketing authorisation application (MAA) confirms that the submission is sufficiently complete to begin the formal review process. Stemline submitted the MAA earlier this month seeking approval of Elzonris for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm.
In November 2018, the MAA was granted accelerated assessment.
