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Browsing Tag

Orphan Drug Designation

2 posts
MMedication
U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome
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U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome

  • August 19, 2026
Teva Pharmaceutical Industries Ltd Ecopipam (EBS-101) is a first-in-class selective D1 (dopamine) receptor antagonist with Orphan Drug designation NDA…
MMedication
Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs
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Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs

  • March 31, 2026
Praxis Precision Medicines, Inc. FDA assigned PDUFA target action date of September 27, 2026 BOSTON, March 30, 2026…
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