Posted by Michael Wonder on 04 Jan 2021
Provention Bio announces U.S. FDA filing of a biologics license application and priority review for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk Individuals
4 January 2020 - FDA sets PDUFA goal date of 2 July 2021.
Provention Bio today announced that the biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals has been filed by the U.S. FDA.
The FDA also granted Provention's request for Priority Review and assigned a user fee goal date of 2 July 2021, under the Prescription Drug User-Fee Act.
