DATA GRAPHICS | Product Development
July 2021 PDUFA dates: Data Byte
July 2, 2021 1:53 AM UTC
At least seven therapies have PDUFA dates in the month of July, five of which have been granted priority review by FDA.
FDA is slated to announce its first decision of the month on Friday on a priority review of teplizumab from Provention Bio Inc. (NASDAQ:PRVB) for Type I diabetes. If approved, the anti-CD3 mAb would be the first therapy available for delaying disease onset in at-risk individuals. In May, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-7 in favor of approving the anti-CD3 mAb. ...