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bpc-157 fda approval status safety warning unapproved peptide risk bpc 157 not approved concerns Understanding the Legal FDA's Review Of Peptides ...

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The FDA’s decision was based on the Phase III APPLAUSE-IgAN study, in which treatment with Fabhalta cut proteinuria by 44% through nine months of follow-up, while placebo comparators saw only a 9% reduction in proteinuria