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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 themselves from severe allergic reactions that could lead to anaphylaxis, today announced that the ...
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 Applications for neffy Under Review with FDA and EMA, Respectivel...
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 Become the First Needle-Free Epinephrine Product for the T...
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 from severe allergic reactions that could lead to anaphylaxis, today announced that the U.S. Food ...
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 themselves from severe allergic reactions that could lead to anaphylaxis, today announced that the U.S. Foo...
New Drug Application and Marketing Authorization Application for neffy ® Currently Under Review with the FDA and EMA; FDA PDUFA Target Action Date Anticipated in Mid-2023 Strong Financial Position with $274.4 Million in Cash, Cash Equivalents and Short-term In...
Data to be Presented in Five Poster Presentations at the 2023 American Academy of Allergy, Asthma and Immunology Annual Meeting Data Support New Drug Application for neffy ® , Currently Under Review with the FDA SAN DIEGO, Feb. 23, 2023 (GLOBE NEWSWIRE) --...
SAN DIEGO, Feb. 22, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced that the company r...
SAN DIEGO, Feb. 09, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today reported that Richard Lowent...
Silverback Therapeutics ( NASDAQ: SBTX ) said the U.S. Food and Drug Administration (FDA) accepted for review ARS Pharmaceuticals' application seeking approval of nasal spray neffy as emergency treatment of allergic reactions (type I) including anaphylaxis in adu...
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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 for approval of a mixed application for marketing authorization based on comprehensi...
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 Authorization Application (MAA) to EMA’s CHMP; CHMP...
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 dose PK/PD study of neffy under NAC conditions and updated ...