Anaphylm pharmacokinetic results unaffected by oral cavity exposure to liquids of different temperatures and pHRemains on track to complete Anaphylm supportive clinical studies and expects to request...
Enforcement Report - Week of June 5, 2024
WARREN, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (Aquestive or the Company), a pharmaceutical company advancing medicines to bring meaningful...
neffy® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024 Response submitted for neffy Marketing...
Met all endpoints in Phase 3 pivotal study for Anaphylm„ (epinephrine) Sublingual Film in first quarter 2024 when compared to EpiPen® and other injectors used for the treatment of anaphylaxisOn track...
CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024 Response addresses all issues previously identified by CHMP, and includes results from a repeat...
Orexo announces that the United States Patent and Trademark Office (USPTO) has granted another US patent specifically related to OX640, Orexo's nasal epinephrine powder product based on the AmorphOX drug delivery platform.
UPPSALA, Sweden, April 17, 2024 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY) today announces that the United States Patent and Trademark Office (USPTO) has granted another US patent specifically related to OX640, Orexo's nasal epinephrine powder product based on the AmorphOX® drug delivery platform.
Endo sues FDA over its handling of generic Adrenalin approvals
Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that...