Recall of bread crumbs upgraded to most urgent as FDA warns of 'reasonable chance of death'

Health authorities have warned of an urgent recall of bread crumbs sold in Colorado due to potentially life-threatening ...
Healio

FDA issues complete response letter to Aquestive for Anaphylm sublingual epinephrine

The FDA cited concerns about human factors in the use of Aquestive Therapeutics’ Anaphylm sublingual film for anaphylaxis and other type 1 allergic reactions in its complete response letter to the ...
The American Journal of Managed Care

FDA Flags Administration Concerns for Aquestive's Noninvasive Epinephrine Film

Aquestive Therapeutics announced it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Anaphylm (dibutepinephrine) Sublingual Film, a noninvasive ...

Aquestive Therapeutics, Inc. (AQST) Discusses FDA Complete Response Letter and Next Steps for Anaphylm Epinephrine Sublingual Film Transcript

Discusses FDA Complete Response Letter and Next Steps for Anaphylm Epinephrine Sublingual Film February 2, 2026 8:00 ...

EURneffy® 1 mg (adrenaline nasal spray) Recommended for Approval in the EU for Emergency Treatment of Type 1 Allergic Reactions, including Anaphylaxis in Children Weighing ≥ ...

EURneffy 1 mg will be the first and only needle-free adrenaline available to younger children in the European UnionARS Pharma’s partner, ...