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- Otsuka’s ADHD approval opens up new drug class with $615M opportunityOtsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
- 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…