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Jul 28, 2026 · Has Dyne Therapeutics received FDA approval? Track FDA approvals, PDUFA dates, and regulatory milestones for …

Jul 20, 2026 · The FDA has granted the BLA Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action …

Jul 20, 2026 · The application has been accepted for Priority Review, and the FDA has assigned a Prescription Drug User Fee Act …

Jul 20, 2026 · What changed today: Filing acceptance with Priority Review, six-month review window, PDUFA date locked to January …

Aug 4, 2025 · Both of Dyne’s lead programs now have FDA Breakthrough Therapy Designation, with DYNE-101 having been granted …

Jul 20, 2026 · The FDA has granted the BLA Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action …

Dyne Therapeutics has announced the pricing of an upsized public offering of 18.3 million shares at $20.50 each, aiming to raise …

20 hours ago · The PDUFA date — also called the target action date or goal date — is when FDA aims to complete its review of an …

Jul 20, 2026 · The PDUFA target action date has been set for January 21, 2027. The application seeks Accelerated Approval based …

Jul 20, 2026 · The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 21, 2027 for Dyne …