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- FDA clears first wearable that continuously tracks both glucose and ketone levelsThe U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
- FDA releases draft guidance on potency testing for immunotherapy productsThe FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…