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- FDA pushes back decision on Capricor’s Duchenne cell therapy, GSK clears hepatitis B drug in JapanThe U.S. Food and Drug Administration has extended its review of Capricor Therapeutics' experimental Duchenne muscular dystrophy cell therapy, deramiocel. The agency moved its decision deadline fro…
- FDA issues early alert on CooperSurgical infant nasal CPAP devices with loose tubing connectionThe FDA’s Center for Devices and Radiological Health has posted an Early Alert about a potential high-risk issue with certain CooperSurgical infant nasal CPAP devices. The problem involves a loose…