Aquestive Therapeutics announces FDA acceptance of new drug application and PDUFA date for Anaphylm for the treatment of severe allergic reactions

Aquestive Therapeutics

16 June 2025 - FDA assigns PDUFA target action date of 31 January 2026

Aquestive Therapeutics today announced that the US FDA has accepted the Company’s new drug application for Anaphylm in the treatment of type 1 allergic reactions, including anaphylaxis.

Read Aquestive Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration