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RNA sequencing and pathway enrichment analysis show FOXO4-DRI significantly downregulates extracellular matrix-receptor interaction pathways, including fibronectin (Fn1), tenascin C (Tnc), and thrombospondin 2 (Thbs2), all critical components of fibrotic tissue architecture

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The matter was remanded back to FDA for reconsideration, and FDA issued a decision in December 2024 confirming the drug shortage was resolved

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