EURneffy 1 mg will be the first and only needle-free adrenaline available to younger children in the European UnionARS Pharma’s partner, ...
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 ...
Aquestive Therapeutics said on Monday the U.S. FDA has declined to approve its oral drug for severe allergic reactions due to ...
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 ...
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 ...
Ward 5 Coun. Matthew Scott and Ward 3's Angela Caputo want EpiPen auto-injectors to be as easily accessible as naloxone or ...
They look cute, familiar or downright boring, yet these creatures quietly help drive a national injury toll that sends ...
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 ...
New community safety zones have been established on parts of Northern Avenue, Pine Street, Fifth Line and Lower Lake Street ...