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 ...

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 ...

Executives from Aquestive Therapeutics (NASDAQ:AQST) said the U.S. Food and Drug Administration has issued a complete ...

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 ...

The FDA has requested new human factors and pharmacology studies for Anaphylm sublingual film following deficiencies in original NDA packaging data.

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 ...

In this interview, Dr. Steve Ward-Smith explores the analytical challenges and opportunities shaping the development of nasal spray therapeutics.

Interim results indicate NS002 demonstrated significantly faster absorption and higher peak epinephrine levels compared to EpiPen 91% of study participants achieved the 100 pg/ml plasma threshold at ...

In a second warning letter, the agency calls out what it says are misleading claims and images in the nasal anaphylaxis ...

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 ...

Regulation, technology and buyer skepticism are pushing historically opaque industries toward radical transparency, and it’s ...