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Even when late-stage data look strong, the FDA still reviews efficacy, adverse events, manufacturing, labeling, contraindications, drug interactions, and risk-management requirements

Under diabetic conditions, hyperglycemia mediated reactive oxygen species (ROS) production and advanced glycation end products (AGEs) accumulation cause DNA damage, which subsequently promotes senescence of renal TECs and glomerular cells (11)

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The synthetic fragment captures the key functional sequences responsible for TB-500's regenerative properties while offering improved stability and standardized production