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ARS Pharmaceuticals Says FDA Schedules Type A Meeting For Neffy By The End Of October

Biopharmaceutical company ARS Pharmaceuticals, Inc. (SPRY) announced Friday that the U.S. Food and Drug Administration (FDA) has scheduled a Type A meeting to discuss the contents of a Complete Response Letter (CRL) previously issued regarding its new drug application (NDA) for neffy (epinephrine nasal spray) for the treatment of allergic reactions (Type I), including anaphylaxis.

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ARS Pharmaceuticals Announces Scheduling of a Type A Meeting with the U S FDA for neffy® (epinephrine nasal spray)

SAN DIEGO, Oct. 06, 2023 ARS Pharmaceuticals, Inc. , a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions.

United statesJustin chakmaRichard lowenthalLaura oneillAllergy drugs advisory committeeDrug administrationExchange commission onAdvisory committee the pulmonaryPharmaceuticals incComplete response letterPulmonary allergy drugs advisory committeeTypei allergic reactionsPrivate securities litigation reform actQuarterly reportExchange commissionInvestor contact

Single and Repeat Dose Clinical Study of neffy (epinephrine nasal spray) Published in the Journal of Allergy and Clinical Immunology

Single and Repeat Dose Clinical Study of neffy (epinephrine nasal spray) Published in the Journal of Allergy and Clinical Immunology
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United statesJustin chakmaSarina tanimotoThomasb casaleLaura oneillAmerican academy of allergyCommittee for medicinal products humanAdvisory committee the pulmonaryPharmaceuticals incUniversity of south floridaExchange commission onTranslational research in allergy immunologyAllergy drugs advisory committeeRepeat dose clinical studyClinical immunologyAmerican academy

StockWatch: Insilico CEO Breaks Down Exelixis Deal

StockWatch: Insilico CEO Breaks Down Exelixis Deal
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FDA rejects neffy epinephrine nasal spray for severe allergic reactions pending further trial data

ASR Pharma said it was surprised and "deeply disappointed" by the FDA request for more trial data on its neffy nasal spray for severe allergic reactions.

United statesAptar pharmaLewis nelsonRichard lowenthalAdvisory committeeAllergy drugs advisory committeeDrug administrationBryn pharmaFood and drug administration