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Tolera Therapeutics granted orphan drug designation for treatment of Type 1 diabetes mellitus.
Tolera Therapeutics Inc was granted orphan drug status by the US Food and Drug Administration (FDA) for TOL101 (anti-TCR murine monoclonal antibody, type IgM), for treatment of recent onset immune-mediated Type 1 diabetes mellitus (T1DM). Designation is granted for treatment of patients sixteen years of age and younger with immune-mediated T1DM and preserved pancreatic beta-cell function, commonly referred to as juvenile diabetes. As an agent with the potential to …
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