- 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.
- UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapyIn briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor's assertion that a Phase 3 trial met its primary outcome measures.