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 ...

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 ...

Shares of US pharma Aquestive Therapeutics rocketed 45.4% to $4.20 this morning, despite receiving a Complete Response Letter ...

From an alleged murder of a woman from nearly 30 years ago to alleged sexual offences committed at a massage business, these ...

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% ...

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 ...