anaphylm

anaphylm: developed by 1 company · 2 FDA decisions. Updated within the last hour.

Development Pipeline (1)

Company	Phase	Indication
Aquestive Therapeutics, Inc. (AQST)	BLA Filed	severe allergic reactions, including anaphylaxis

FDA Decisions

CRLType I allergic reactions(AQST)

Feb 2, 2026

FDA_MeetingFDA accepted the NDA for Anaphylm and assigned a PDUFA target action date of 2026-01-31; would be first oral epinephrine if approved.(AQST)

Jun 16, 2025

Frequently asked questions

Who is developing anaphylm?

anaphylm is being developed by Aquestive Therapeutics, Inc..

What is anaphylm's latest FDA decision?

The most recent tracked FDA decision for anaphylm is CRL for Type I allergic reactions, dated February 2, 2026.

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