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Browsing Tag

Prescription Drug User Fee Act

2 posts
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…
MMedication
FDA Confirms Direct Review Path For Aquestive's Allergy Treatment
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FDA Confirms Direct Review Path For Aquestive’s Allergy Treatment

  • September 9, 2025
The U.S. Food and Drug Administration (FDA) on Thursday informed Aquestive Therapeutics, Inc. (NASDAQ:AQST) that an advisory committee…
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