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Category: EMDAC

  • The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes

    Shots: EMDAC has voted 10-7, confirming that the benefits of teplizumab outweigh the risks supporting the approval to delay T1D Mellitus The recommendation is based on a pivotal TN-10 study in which a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least 2yrs. in pre symptomatic patients with stage […]