The company has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) — a critical regulatory step. This product is now ready to be converted into a finished drug product.
The approval of neffy marks the first major advancement in epinephrine delivery for patients over four years of age in more ...
Continuous exposure of either cell type (ie, HTM or SCE cells) to EPI or ISO resulted in a four- to eightfold increase with a maximal effect measured around 10 hours and a half maximal effect at 2 ...
The FDA has approved neffy 1 mg epinephrine nasal spray for treating anaphylaxis and other type 1 allergic reactions in ...
Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 ...
US FDA approves ARS Pharma’s neffy 1 mg to treat type I allergic reactions for paediatric patients weighing 15 to less than 30 kilograms: San Diego Friday, March 7, 2025, 09:00 ...