BLA Resubmission Archives

Provention Bio Gets Another Shot at Delaying Diabetes

Biologics License Application (BLA), BLA Resubmission, Breakthrough Therapy Designation, Clinical Trials, Complete Response Letter, FDA, R&D, Type 1 Diabetes

Provention Bio is resubmitting a Biologics License Application (BLA) for teplizumab, a drug intended to delay the onset of Type 1 diabetes (T1D) in at-risk individuals, following a Type B pre-BLA resubmission meeting with the U.S. Food and Drug Administration.

January 28, 2022/by BioSpace

Enzyvant Resubmits BLA for Pediatric Congenital Athymia Drug

Biologics License Application (BLA), BLA Resubmission, Complete Response Letter, FDA, Immune Disorders, PDUFA, Pediatric, Pediatric Congenital Athymia, Regenerative Tissue, Reuters

Enzyvant Sciences resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the company’s tissue-based regenerative pediatric congenital athymia therapy RVT-802.

April 27, 2021/by Andrew Humphreys