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Specifically, at day 7, there is an infiltration of inflammatory cells while controls presented prominent edema, disintegrated reticulin fiber network, and no proliferation of collagen fibers (Figure 9 and Figure 10), and reduction of capillaries with survived arterioles of the myotendinous junction

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Both were removed from FDA's Category 2 interim-policy list in April 2026 following withdrawn nominations, and an FDA advisory committee narrowly recommended them for the 503A Bulks List in July 2026 with no final FDA rule yet