Posted by Michael Wonder on 21 Mar 2022
Provention Bio announces FDA acceptance of the biologics license application resubmission for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals
21 March 2022 - FDA Sets Goal Date of August 17, 2022.
Provention Bio today announced that the resubmitted biologics license application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals has been considered a complete, class 2 response to the July 2021 action letter by the U.S. FDA.
