A Prescription Drug User Fee Act target date of January 31, 2026 has been set for the application. The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for epinephrine ...

Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window CHICAGO -- A ...

Please provide your email address to receive an email when new articles are posted on . Aquestive aims to submit a new drug application in the first quarter of 2025. The company hopes to launch in ...

Please provide your email address to receive an email when new articles are posted on . The AQST-109 sublingual film provides needle-free delivery of epinephrine. AQST-109 achieved faster time to ...

LOUISVILLE, Ky. -- A sublingual film may be able to deliver epinephrine as effectively as intramuscular injections and provide an alternate pathway for urgent treatment of allergic anaphylaxis, a ...

When you take a medication sublingually, you place it under the tongue. Taking a medication buccally involves placing it between your gums and cheek. With both, the drug absorbs into your blood.

Regulatory submission to expand the label for Igalmi use in the outpatient setting is expected in the first quarter of 2026. At-home administration of dexmedetomidine sublingual film as a treatment ...

An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) can rapidly relieve mild to moderate acute agitation in patients with bipolar disorder (BD), ...

Peanut sublingual immunotherapy (SLIT) given in extended therapy up to 5 years provides significant desensitization for most peanut-allergic children, and is easy to use and safe, say the authors of a ...