Posted by Michael Wonder on 13 Aug 2018
Stemline Therapeutics announces that FDA accepts Elzonris biologics license application and grants priority review
13 August 2018 - Stemline Therapeutics announced today that the U.S. FDA has accepted for filing the company’s biologics license application for Elzonris (tagraxofusp; SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm,
The FDA also granted priority review for the application and has set a target action date of 21 February 2019, under the Prescription Drug User Fee Act.
Elzonris has also been granted breakthrough therapy designation and orphan drug designation by the FDA.
