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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 

William blairAllergy drug advisory committeePharmaceuticals incComplete response letterDrug applicationAllergic reactionsPulmonary allergy drug advisory committeeMarket perform

FDA declines to approve first needle-free option to EpiPen

Federal regulators have declined to approve the first needle-free epinephrine treatment for people who suffer from severe allergic reactions, requesting its developer, ARS Pharmaceuticals, to conduct further testing.

United statesRichard lowenthalDrug administrationPulmonary allergy drug advisory committeeComplete response letterFood and drug administration

FDA Panel Votes on Intranasal Epinephrine for Treating Severe Allergic Reactions

The majority of FDA panel members voted positively regarding the benefits of neffy, an intranasal formulation of epinephrine.

Richard lowenthalAllergy drug advisory committeeAllergy drug advisory committee meetingDrug administrationPulmonary allergy drug advisory committee

ARS Pharmaceuticals Highlights Progress and Reports First Quarter 2023 Financial Results

FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy® for the Treatment of Allergic Reactions , Including Anaphylaxis New Drug and Marketing Authorization. | May 15, 2023

United statesRichard lowenthalJustin chakmaEric karasAdvisory committeeDrug administrationPharmaceuticals incAllergy drug advisory committeeEuropean medicines agencyDivision of pulmonaryExchange commission onCommittee votesFavorable benefit risk profileAllergic reactionsMarketing authorization applicationsUnder review

FDA Committee Votes in Favor of Intranasal Epinephrine for Severe Allergic Reactions Including Anaphylaxis

It was announced by ARS Pharmaceuticals, Inc., that a US Food and Drug Administration Drug Advisory Committee voted in favor of a new intranasal epinephrine treatment for severe allergic reactions.

United statesRichard lowenthalGrossig david dworaczykDrug administrationAllergy drug advisory committeeAdvisory committee votes in support of favorablePharmaceuticals incPulmonary allergy drug advisory committeeNew drug applicationDrug user fee actChief executive officerCommittee votesFavorable benefit risk profileAllergic reactionsIncluding anaphylaxisPublished may

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