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Browsing Tag

NDA

3 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
Is It Too Late To Consider Revolution Medicines (RVMD) After Its Recent 50% Weekly Surge?
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Does FDA’s Rolling Review Of COMP360 Psilocybin Depression Therapy Change The Bull Case For COMPASS Pathways (CMPS)?

  • May 5, 2026
In April 2026, COMPASS Pathways announced that the FDA granted a rolling NDA review for its synthetic psilocybin…
GGenetics
Saol Therapeutics hit with CRL for rare genetic disease
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Saol Therapeutics hit with CRL for rare genetic disease

  • September 10, 2025
The U.S. FDA issued a complete response letter (CRL) for the NDA to privately held Saol Therapeutics Inc.’s…
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