Provention bio provides regulatory update on biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals

Red bank, n.j., april 8, 2021 /prnewswire/ -- provention bio, inc. (nasdaq: prvb), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the company received a notification on april 2, 2021 from the u.s. food and drug administration (fda), stating that, as part of its ongoing review of the company's biologic license application (bla) for teplizumab for the delay or prevention of clinical type 1 diabetes, the fda has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
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