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 US Food and Drug Administration (FDA) has approved Neffy, a nasal spray for treating severe allergic reactions in children aged 4 and above. This is the first emergency allergy treatment ...
The approval of neffy marks the first major advancement in epinephrine delivery for patients over four years of age in more ...
1Glenmark's Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial is only approved for the indication(s) listed in Glenmark's approved label. 2Market includes brand and all available ...
Parents and pediatricians just gained one more tool to combat severe allergic reactions in young kids. San Diego-based ARS ...
Richmond, Virginia, March 17, 2025 (GLOBE NEWSWIRE) -- Phlow Corp., a U.S.-based certified B Corporation on a mission to bring medicines to life through advanced development and manufacturing in ...