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analyzed the effects of Isatuximab, the second anti-CD38 reagent approved by the FDA, on NK cells, which express CD16, a low affinity FcR ( Overall, these results suggest that some of the therapeutic actions of the antibody are mediated by direct signaling through the CD38 molecule, without the effects driven by FcRs, at least in the NK cells tested in vitro

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The FDA does inspect compounding pharmacies but does not test every individual batch

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