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ARS Pharmaceuticals Announces PDUFA Date Extension for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis

ARS Pharmaceuticals Announces PDUFA Date Extension for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
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United statesRichard lowenthalLaura oneillMonique allaireJustin chakmaDrug administrationPharmaceuticals incWhile the agencyExchange commissionEuropean medicines agencyAllergy drug advisory committeeStrategic communicationsAdditional time neededPost marketing requirements discussionsPrescription drug user fee actNew drug application

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 Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis

FDA Advisory Committee Votes: neffy Data Support a Favorable Benefit-Risk Assessment in Adults and in Children <18 years of age and ≥30 kg If Approved, neffy Will Become the First Needle-Free. | May 11, 2023

United statesLaura oneillCarlos camargoRichard lowenthalJustin chakmaDrug administrationPharmaceuticals incHarvard medical schoolAllergy drug advisory committeeFda advisory committeeExchange commissionCommittee votesData supportFavorable benefit risk assessmentWill becomeFirst needle free epinephrine product

FDA Advisory Committee Votes in Support of Favorable

FDA Advisory Committee Votes: neffy Data Support a Favorable Benefit-Risk Assessment in Adults (16:6 in Favor) and in Children <18 years of age and ≥30.

United statesLaura oneillRichard lowenthalCarlos camargoJustin chakmaAllergy drug advisory committeePharmaceuticals incExchange commissionDrug administrationHarvard medical schoolFda advisory committeeCommittee votesData supportFavorable benefit risk assessmentWill becomeFirst needle free epinephrine product

ARS Pharmaceuticals (SPRY) Announces FDA AdCom s Favorable Vote for neffy

ARS Pharmaceuticals (SPRY) Announces FDA AdCom s Favorable Vote for neffy
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United statesCarlos camargoRichard lowenthalDrug administrationJustin chakmaars pharmaceuticalsExchange commissionPharmaceuticals incHarvard medical schoolAllergy drug advisory committeePulmonary allergy drug advisory committeeChief executive officerEmergency medicineHarvard medicalNew drug applicationPrescription drug user fee actTypei allergic reactions