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Interestingly, murine studies suggest that TN-X is involved in the later stages of wound healing when matrix remodeling enhances biomechanical strength of the dermis, which could explain the mild skin fragility noted in these patients

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The executive submission, filed by BakerHostetler on behalf of AAPM for the July 2324, 2026 Pharmacy Compounding Advisory Committee meeting, explicitly frames the case around the four criteria in 21 CFR 216.23(c), then backs that framework with a curated exhibit stack: chemistry, clinical monographs, manufacturing quality, prospective studies, real-world safety, utilization history, and institutional support

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