Sanofi Auvi Q News Today : Breaking News, Live Updates & Top Stories | Vimarsana

U.S. health regulators declined to approve a nasal spray that would have been the first needle-free emergency treatment for allergic reactions and asked for further tests, a move that left its developer ARS Pharmaceuticals "very surprised". ARS Pharma's Neffy is to be an alternative to EpiPen and other autoinjectors like Sanofi's Auvi-Q filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions. The U.S. Food and Drug Administration (FDA), in its so-called "Complete Response Letter", asked the company to complete a repeat-dose study on the treatment before a potential approval, rather than after as was mutually agreed in August, ARS Pharma said late on Tuesday. ....

United States , Sanofi Auvi , Jahnavi Nidumolu , Christy Santhosh , Maju Samuel , James Tarbox , Richard Lowenthal , Dhanya Ann Thoppil , Sriparna Roy , Texas Tech University Health Sciences Center , Drug Administration , Advisory Committee , Sanofi Auvi Q , Texas Tech University Health Sciences , Nasal Spray , Jrs Pharma , Richard Lowenthal , Allergic Reactions , Us Food And Drug Administration , Ars Pharmaceuticals ,