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 ...

I spoke to the Hawaii Japanese Heritage Group this past weekend about noteworthy Americans of Japanese ancestry and their ...

FDA has approved Vybrique, the first oral film formulation of sildenafil for the treatment of erectile dysfunction, offering ...

Aquestive plans a Type A FDA meeting and expects NDA resubmission in Q3 2026 after required studies.

Take it from a local. If you find yourself in the LA area's "deep valley," these are among the best restaurants serving the ...

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 ...

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

Our understanding of migraine is starting to shift, overturning ideas of what's a symptom and what's a trigger, and which ...

Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 ...

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

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 ...

Discusses 2026 Clinical Pipeline Outlook and Anticipated Trial Updates February 2, 2026 7:01 PM ESTCompany ParticipantsGary ...