FDA accepts Aquestive Therapeutics' Anaphylm NDA resubmission; PDUFA date set for March 16, 2027

The FDA has accepted Aquestive Therapeutics' resubmitted New Drug Application for Anaphylm, its needle-free epinephrine film, with a PDUFA goal action date set for March 16, 2027.

Detected & updated continuously · Source: Nebula