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The FDAs approval, which is for both subcutaneous and intravenous formulations of Otulfi, was backed by a thorough evaluation of a comprehensive data package, which included analytical, preclinical, clinical and manufacturing data, according to the companies

It also modulated gut microbiota composition, lowering the Firmicutes/Bacteroidetes ratio and improving intestinal barrier function by increasing expression of tight junction proteins such as ZO-1, occludin, and claudin-1

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8C) as compared with MTX-treated rats, but the three properties were still showing a decrease compared with the control group

Molecules 24 , 2961 (2019)