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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...
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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...
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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...
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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...
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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...
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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...
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SAN DIEGO, March 06, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect...
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neffy demonstrated statistically significant and clinically meaningful improvement in pruritus, hives, body surface area and erythema in treatment-resistant chronic spontaneous urticaria patients, a...
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SAN DIEGO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients...
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Repeat doses of neffy under nasal allergen challenge demonstrate a pharmacokinetic profile greater than or similar to injection, and a pharmacodynamic profile greater than injection Company believes...