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Ars Pharmaceuticals

All articles tagged with #ars pharmaceuticals

health2 years ago•5 min saved

FDA Rejects Neffy Epinephrine Nasal Spray for Severe Allergic Reactions

The FDA has declined to approve Neffy, an epinephrine nasal spray developed by ARS Pharmaceuticals, citing the need for more trial data to evaluate the safety of repeated doses. Neffy, which would provide a needle-free option for treating severe allergic reactions, was expected to be approved for use in adults and children weighing over 30 kilograms. The decision comes as a disappointment to many families of children with severe allergies who prefer to avoid needles. The drugmaker plans to conduct the requested trial as quickly as possible to meet the needs of patients.

via CBS News|

#ars-pharmaceuticals #epinephrine-nasal-spray #fda

stock-market2 years ago•2 min saved

Pinterest Soars on Revenue Growth Forecasts, Instacart and Coty Also See Significant Stock Movement

Stock futures edged higher as investors awaited the second day of the Fed's policy meeting. Bausch Health saw a 6% increase after an upgrade from Jefferies, while Pinterest's stock rose over 5% following positive sentiment from Wall Street firms. Coty shares also climbed more than 5% after the company upgraded its forecasts. On the downside, Instacart's stock dropped over 5% after a volatile debut, and ARS Pharmaceuticals shares plummeted over 50% as the FDA declined to approve its nasal spray treatment.

via Seeking Alpha|

#ars-pharmaceuticals #bausch-health #coty

healthcare2 years ago•6 min saved

FDA Panel Approves Needle-Free Epinephrine Alternative for Anaphylaxis.

An advisory committee of outside experts to the FDA voted in favor of ARS Pharmaceuticals’ EpiPen alternative for adults and children, which would be the first epinephrine nasal spray on the US market. The FDA advisory committee's vote was a surprise as multiple members questioned the nasal spray’s benefit-risk profile and called for some clinical data on the nasal spray to be produced before it can be approved. Meanwhile, the FDA has rejected ImmunityBio’s biologics license application for a specific bladder cancer, and the biotech’s shares tumbled about 50% before the opening bell Thursday.

via Endpoints News|

#ars-pharmaceuticals #epipen #fda