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Rocket said it has met with leaders from the FDA’s Center for Biologics Evaluation and Research (CBER) to “align on the limited scope” of additional chemistry, manufacturing and controls (CMC) information and support Kresladi’s approval as soon as possible
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Tissue Histology for Morphology, Lipid Content and Fibrosis Heart and liver tissue samples were collected at the time of sacrifice and fixed in a 10% zinc formalin buffered solution (CUNZF-5-G, Azer Scientific, Morgantown, PA, USA) for 48 hours, followed by transfer to a storage solution of 0.01% sodium azide in PBS
