EURneffy (adrenaline nasal spray) Approved in the EU as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis)
August 26, 2024 09:29 ET
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ARS Pharmaceuticals, Inc.
EURneffy offers adults and children (≥30 kg) in Europe living with severe allergic reactions the first new delivery method for adrenaline in more than 30 years in the EU European Commission decision...
ARS Pharmaceuticals Receives FDA Approval of neffy® (epinephrine nasal spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis
August 09, 2024 12:49 ET
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ARS Pharmaceuticals, Inc.
neffy Offers Adults and Children (≥30 kg) Living with Severe Allergic Reactions the First New Delivery Method for Epinephrine in more than 35 Years Well-capitalized to Support Launch and...
ARS Pharmaceuticals to Participate in the 2024 Wedbush PacGrow Healthcare Conference
August 07, 2024 09:01 ET
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ARS Pharmaceuticals, Inc.
SAN DIEGO, Aug. 07, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect...
ARS Pharmaceuticals Provides Business Highlights and Reports Second Quarter 2024 Financial Results
August 06, 2024 16:01 ET
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ARS Pharmaceuticals, Inc.
neffy® (epinephrine nasal spray) New Drug Application (NDA) under review by FDA; discussions are ongoing to finalize labeling with FDA; PDUFA date in early October 2024 EURneffy® (adrenaline nasal...
ARS Pharmaceuticals Announces EURneffy (adrenaline nasal spray) Recommended for Approval by CHMP for Emergency Treatment of Allergic Reactions (anaphylaxis)
June 28, 2024 06:30 ET
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ARS Pharmaceuticals, Inc.
EURneffy positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in Europe Positive CHMP opinion and recommendation...
ARS Pharmaceuticals Highlights neffy Regulatory Progress and Reports First Quarter 2024 Financial Results
May 09, 2024 16:05 ET
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ARS Pharmaceuticals, Inc.
neffy® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024 Response submitted for neffy Marketing...
ARS Pharmaceuticals Submits Response for neffy® (epinephrine nasal spray) Marketing Authorization Application to EMA’s CHMP and Enters License Agreement with CSL Seqirus for Commercialization of neffy in Australia and New Zealand
April 30, 2024 09:01 ET
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ARS Pharmaceuticals, Inc.
CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024 Response addresses all issues previously identified by CHMP, and includes results from a repeat...
ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)
April 03, 2024 09:01 ET
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ARS Pharmaceuticals, Inc.
Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that...
ARS Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results
March 21, 2024 16:05 ET
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ARS Pharmaceuticals, Inc.
Preparing to submit response to the FDA’s CRL for neffy® (epinephrine nasal spray) in Type I allergic reactions in early Q2 2024, following successful completion of neffy repeat dose nasal allergen...
ARS Pharmaceuticals Reviews Recent Clinical Updates and Commercial Opportunity at neffy® Investor Day
March 07, 2024 16:05 ET
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ARS Pharmaceuticals, Inc.
Significant unmet need with 80-90% of patients with current epinephrine Rx not using as directed, and only ~15% of diagnosed severe Type I allergy population with a current epinephrine...