It’s not often that disclosure of a complete response letter (CRL) causes a company’s share price to rise, but that was case for Aquestive Therapeutics Inc., which saw its stock (NASDAQ:AQST) rise 39% ...
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 ...
Join over 14,000 individuals and families managing food allergies who are sharing their food allergy stories and making a ...
The FDA has delayed approval of Aquestive Therapeutics’ new drug application seeking approval of Anaphylm, a sublingual epinephrine film for the treatment of Type 1 allergic reactions, including ...
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 UnionARS Pharma’s partner, ...
Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 ...
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 setback to its efforts to enter the allergy ...
Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 2026Remains well-capitalized and anticipates ending 2026 ...
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 ...
Anaphylaxis triggered by iodinated contrast media was rare, but severe and refractory cases indicated the need for ...
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