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Teva's ecopipam shows 69.8% tic reduction at 8 weeks and sustained efficacy at 18 months, with FDA Priority Review underway.
Teva's ecopipam D1 antagonist gains peer-reviewed support in pediatric Tourette syndrome, with Phase 3 data showing 50% relapse reduction.
FDA's October 29 webinar addresses ICH M15 MIDD documentation standards, offering regulatory teams direct access to FDA scientists before submission.
FDA expands Camzyos approval to adolescents aged 12–17 with oHCM, based on Phase 3 SCOUT-HCM trial data, triggering label and REMS review obligations.
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