Provention Bio, Inc. (Nasdaq: PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended its review period by three months for the Biologics License Application (BLA) for teplizumab. The extended User Fee Goal date is November 17, 2022.
The Company was also informed that if no major deficiencies are identified during the review period, the FDA plans to communicate proposed labeling and, if necessary, any post-marketing requirement or commitment requests by October 17, 2022.
https://finance.yahoo.com/news/provention-bio-announces-extension-fda-200100558.html
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