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Benzinga
Benzinga
Business
Vandana Singh

FDA Confirms Direct Review Path For Aquestive's Allergy Treatment

FDA Allergy AQST
biotech lab

The U.S. Food and Drug Administration (FDA) on Thursday informed Aquestive Therapeutics, Inc. (NASDAQ:AQST) that an advisory committee meeting is not required for Anaphylm (dibutepinephrine) Sublingual Film.

The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm remains January 31, 2026.

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