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ARS Pharmaceuticals' EpiPen Alternative Delayed US Approval - Two Analysts Offer Differing Views

On Tuesday, The FDA issued a Complete Response Letter regarding ARS Pharmaceuticals Inc's SPRY New Drug Application (NDA) for neffy (epinephrine nasal spray)… ....

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ARS Pharmaceuticals' EpiPen Alternative Delayed US Approval - Two Analysts Offer Differing Views - ARS Pharmaceuticals (NASDAQ:SPRY)

On Tuesday, The FDA issued a Complete Response Letter regarding ARS Pharmaceuticals Inc's (NASDAQ: SPRY) New Drug Application (NDA) for neffy (epinephrine nasal spray) in the treatment of Allergic Reactions (Type I), including anaphylaxis (fatal allergic reaction) for  ....

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FDA Issues Complete Response Letter for neffy® (epinephrine

Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under. ....

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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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FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study

Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced allergic rhinitis conditions FDA. ....

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