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Cingulate Receives $4.3M Waiver from FDA Ahead of Imminent Filing for Marketing Approval of Lead ADHD Asset CTx-1301
Globenewswire· 2025-07-29 12:00
PDUFA Fee Waiver comes Days before Planned Submission of New Drug Application KANSAS CITY, Kan., July 29, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it has received a fiscal year 2025 PDUFA (Prescription Drug User Fee Act) fee waiver from the U.S. Food and Drug Administration (FDA) ...