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Teplizumab FDA Approval Status

FDA Approved: No
Generic name: teplizumab
Company: Provention Bio, Inc.
Treatment for: Prevention of Type 1 Diabetes

Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) in development for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals.

Development Timeline for teplizumab

DateArticle
Mar  3, 2021Provention Bio Announces Publication of Extended Follow-up Data from the Pivotal "At-Risk" TN-10 Study of Teplizumab in Science Translational Medicine
Jan  4, 2021Provention Bio Announces U.S. FDA Filing of a Biologics License Application (BLA) and Priority Review for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-risk Individuals
Nov  2, 2020Provention Bio Completes Rolling Submission of the Biologics License Application (BLA) for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-risk Individuals
Jun 15, 2020Provention Bio's Teplizumab Continued to Significantly Delay the Onset of Insulin-Dependent Type 1 Diabetes (T1D) in Presymptomatic Patients
Apr  9, 2019Provention Bio Initiates Phase 3 PROTECT Clinical Trial with PRV-031 (Teplizumab) in Patients with Recent Onset Type 1 Diabetes

Further information

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