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Patients can request a prescription from their existing healthcare provider, or meet with a physician virtually, to request a prescription for neffy ahead of product availability expected by late...
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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...
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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...
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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...
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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...
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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...