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- Otsuka receives FDA approval for Simtriyo, first norepinephrine-dopamine-serotonin reuptake inhibitor for ADHDOtsuka Pharmaceutical announced that the FDA has approved its daily pill centanafadine, branded as Simtriyo, for the treatment of attention-deficit hyperactivity disorder in patients six years and…
- FDA says Capricor's DMD cell therapy failed to meet Phase 3 endpointsThe FDA briefing documents released before an advisory committee meeting state that the Phase 3 trial of Capricor's deramiocel did not achieve its pre-specified primary and secondary efficacy endpo…