Aquestive Therapeutics Gets FDA Feedback on Anaphylm – Quick Resolution Expected
Aquestive Therapeutics receives FDA Complete Response Letter for Anaphylm with packaging-related deficiencies. Company plans rapid resolution and Q3 2026 resubmission.
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Aquestive Therapeutics Faces FDA Setback for Anaphylm Drug Approval
Aquestive Therapeutics stock plunges after FDA identifies deficiencies in Anaphylm application, a sublingual film treatment for severe allergic reactions.
Aquestive's Anaphylm: Needle-Free Epinephrine on Track for FDA Approval
Anaphylm, Aquestive's needle-free sublingual epinephrine film for severe allergic reactions, is on track for FDA approval by Jan 31, 2026. It offers a device-free, orally delivered alternative to overcome needle fear.