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Provention Bio Provides Regulatory Update for Teplizumab At-Risk Type 1 Diabetes Approval Pathway

Provention Bio Provides Regulatory Update for Teplizumab At-Risk Type 1 Diabetes Approval Pathway

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RED BANK, N.J., Nov. 22, 2021 /PRNewswire/ — Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today provided an update on its ongoing efforts to address U.S. Food and Drug Administration (FDA) considerations cited in the Complete Response Letter (CRL) issued to the Company by the FDA on July 2, 2021, pertaining to comparability between the Company’s planned teplizumab commercial product and clinical drug product used in historical trials of teplizumab.

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