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The FDA's guidance on off-label prescribing acknowledges that physicians may prescribe approved drugs off-label, but peptides like BPC-157 are not FDA-approved drugs at all

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Recent work demonstrated that sEVs loaded with semaglutide or tirzepatide crossed the gut barrier intact and produced significant 4-hour post-prandial glucose reductions in mice without inducing detectable anti-drug antibodies, underscoring their innate immune stealth [174]