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...
ARS Pharmaceuticals expects to launch neffy (epinephrine nasal spray) in H2 2024, for which the company plans to submit a response to the complete response letter (CRL) issued by the US Food and Drug Administration (FDA) in September 2023.
Aquestive Therapeutics Announces Pivotal Study for Anaphylm
ARS Pharmaceuticals Reviews Commercial Opportunity at neffy Investor Day
Enforcement Report - Week of February 28, 2024
Repeat doses of neffy under nasal allergen challenge demonstrate a pharmacokinetic profile greater than or similar to injection, and a pharmacodynamic profile greater than injection Company believes...