ARS Pharmaceuticals Announces Presentation of Clinical Data Supporting neffy® (epinephrine nasal spray) for the Treatment of Allergic Reactions (Type I) including Anaphylaxis
09 nov. 2023 11h02 HE
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ARS Pharmaceuticals, Inc.
Data to be Presented in Four Oral Presentations and Posters at the 2023 American College of Allergy, Asthma and Immunology Annual Scientific Meeting Supports neffy’s potential to be a safe and...
ARS Pharmaceuticals Announces Scheduling of a Type A Meeting with the U.S. FDA for neffy® (epinephrine nasal spray)
06 oct. 2023 09h03 HE
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ARS Pharmaceuticals, Inc.
SAN DIEGO, Oct. 06, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients...
Single and Repeat Dose Clinical Study of neffy (epinephrine nasal spray) Published in the Journal of Allergy and Clinical Immunology
03 oct. 2023 09h03 HE
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ARS Pharmaceuticals, Inc.
neffy resulted in robust responses on pharmacodynamic (PD) surrogates of efficacy observed even at 1 minute after dosing, and which were comparable to, or greater in magnitude than, EpiPenRepeat doses...
FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study
19 sept. 2023 22h49 HE
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ARS Pharmaceuticals, Inc.
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...
ARS Reports Second Quarter 2023 Financial Results and Provides Business Updates
10 août 2023 16h00 HE
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ARS Pharmaceuticals, Inc.
ARS continues engagement with U.S. FDA on final labeling and post-marketing commitments for the neffy® new drug application; PDUFA target action date set for September 19, 2023 Ended second quarter...
ARS Pharmaceuticals Announces PDUFA Date Extension for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
20 juin 2023 08h00 HE
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ARS Pharmaceuticals, Inc.
SAN DIEGO, June 20, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect...
ARS Pharmaceuticals Highlights Progress and Reports First Quarter 2023 Financial Results
15 mai 2023 09h00 HE
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ARS Pharmaceuticals, Inc.
FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy® for the Treatment of Allergic Reactions (Type I), Including Anaphylaxis New Drug and Marketing Authorization...
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
11 mai 2023 19h01 HE
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ARS Pharmaceuticals, Inc.
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 kg (17:5 in Favor)If Approved, neffy Will...
ARS Pharmaceuticals Announces Availability of Briefing Documents for FDA Advisory Committee Meeting on neffy® for the Treatment of Type I Allergic Reactions Including Anaphylaxis
09 mai 2023 09h10 HE
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ARS Pharmaceuticals, Inc.
SAN DIEGO, May 09, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves...
ARS Pharmaceuticals Announces FDA Advisory Committee for neffy® for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
28 mars 2023 09h39 HE
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ARS Pharmaceuticals, Inc.
SAN DIEGO, March 28, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect...