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On April 30, 2026, the FDA further proposed formally excluding both from the 503B Bulks List - a proposal that, if finalized after the June 29, 2026 comment period, would close the remaining large-scale outsourcing facility pathway

Dysbiosis amplifies barrier dysfunction and immune activation, while inflammation further perturbs microbial composition and impairs epithelial repair, establishing a self-sustaining pathological cycle

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