Posted by Michael Wonder on 06 Jul 2021
Provention Bio receives complete response letter to biologics license application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals
6 July 2021 - Previously reported pharmacokinetic drug product comparability considerations remain outstanding.
Provention Bio today announced that the U.S. FDA has issued a complete response letter for the Company's biologics license application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals.
