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- FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy reviewThe FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…
- FDA clears Abbott’s Libre Duo 10-Day sensor to warn of diabetic ketoacidosisThe U.S. Food and Drug Administration has cleared Abbott’s new wearable device that measures both glucose and ketone levels in people with diabetes. The clearance allows the product to be marketed…