7/103 sources · 2 publishersUpdated Oct 15, 18:36 UTC
FDA Accepts Aquestive’s Anaphylm Resubmission and Sets March 2027 Review Deadline
Aquestive Therapeutics said on October 15, 2026 that the U.S. Food and Drug Administration will review its updated application for Anaphylm, an under-the-tongue epinephrine film for severe allergic reactions. The agency assigned March 16, 2027 as the target date for completing its assessment after the company submitted information addressing earlier regulatory concerns.
Why it matters
The decision moves Anaphylm into another formal FDA review phase, but it does not establish that the treatment will be approved. Aquestive says the product could provide a needle-free way to administer epinephrine if cleared.
Key facts
- 1The FDA classified the updated application as a Class 2 response and accepted it as complete. rttnews.com
- 2The FDA’s target date for finishing its review is March 16, 2027. tradingview.com
- 3Anaphylm is designed as a sublingual oral film containing epinephrine for severe allergic reactions, including anaphylaxis. rttnews.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.