Discusses FDA Complete Response Letter and Next Steps for Anaphylm Epinephrine Sublingual Film February 2, 2026 8:00 ...
EURneffy 1 mg will be the first and only needle-free adrenaline available to younger children in the European Union ...
EURneffy 1 mg will be the first and only needle-free adrenaline available to younger children in the European UnionARS Pharma’s partner, ...
Employers must assess each employee’s ability to perform essential job functions on a case-by-case basis using objective ...
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 ...
Pediatricians are demanding allergy training for all daycare workers, warning that children’s lives are endangered by ...
By Padmanabhan Ananthan Feb 2 (Reuters) - Aquestive Therapeutics said on Monday the U.S. FDA has declined to approve its oral drug for severe allergic reactions due to packaging issues, marking a ...
The FDA issued complete response letters (CRLs) to two companies in recent days, resulting in vastly different reactions from the market. | The FDA issued complete response letters to Aquestive ...
Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 ...
A few months after sending an untitled letter to ARS Pharmaceuticals, taking issue with certain aspects of a TV commercial about its epinephrine nasal spray, the FDA is reiterating its concerns about ...
Executives from Aquestive Therapeutics (NASDAQ:AQST) said the U.S. Food and Drug Administration has issued a complete ...
In a second warning letter, the agency calls out what it says are misleading claims and images in the nasal anaphylaxis ...
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