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- FDA Approves First Gene Therapy for Young Children with Sickle Cell DiseaseThe U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…fda press · 29d ago↗ source
- FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug ManufacturingFDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…fda press · 1mo ago↗ source
- FDA Clears First Over-the-Counter Continuous Glucose Monitor for ChildrenThe U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…