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US FDA declines to approve ARS' emergency nasal spray for allergic reactions

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. ....

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