Aquestive Therapeutics Receives FDA Letter Identifying Deficiencies That Preclude Labeling Discussions For Anaphylm (Dibutepinephrine) Sublingual Film
Benzinga Newsdesk 9 months ago
BiotechNewsHealth CareFDAGeneral
Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time Receives confirmation from FDA that Agency's review of Anaphylm NDA application is
- Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time
- Receives confirmation from FDA that Agency's review of Anaphylm NDA application is ongoing and no final FDA decision has been made
- Progresses global regulatory expansion activities in Canada, Europe, and the United Kingdom for Anaphylm
- Unaudited cash and cash equivalents of approximately $120 million as of December 31, 2025