ARS Pharmaceuticals Inc. (SPRY) said that the U.S. Food and Drug Administration's Pulmonary-Allergy Drug Advisory Committee (PADAC) voted 16:6 in favor for adults, and 17:5 in favor for children, that available data support a favorable benefit-risk assessment for neffy in the treatment of severe allergic reaction (Type 1), including anaphylaxis, for adults and children who weigh more than 30kg.
While PADAC recommendations are non-binding, the FDA will consider this outcome in its review of the pending New Drug Application (NDA) for neffy.
The company noted that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date anticipated mid-2023. If approved, neffy would be the first non-injectable treatment available to patients with allergic reactions (Type 1) including anaphylaxis.
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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.