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Severe Allergic Reactions

All articles tagged with #severe allergic reactions

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

health2 years ago•4 min saved

FDA Requests More Data for Needle-Free Epinephrine Alternative

The US Food and Drug Administration (FDA) has declined to approve a needle-free epinephrine nasal spray for the treatment of severe allergic reactions. The FDA requested more data from drugmaker ARS Pharmaceuticals, including a study on repeat doses. The decision comes despite a positive recommendation from an independent advisory committee. If approved, the nasal spray, called Neffy, would be the first needle-free epinephrine treatment. The FDA's decision has disappointed patient advocacy groups who believe a nasal spray option would provide more options and be easier to use for people with severe allergies. ARS Pharmaceuticals plans to resubmit the necessary data in the first half of 2024.

via CNN|

#fda #health #nasal-spray