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- FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinicsThe U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
- FDA grants accelerated approval to Genglycos, first therapy for glycogen storage disease type IaThe U.S. Food and Drug Administration issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), marking the first therapy for patients aged eight years and older with glycogen…