Por: CBS News Politics September 20, 2023
The Food and Drug Administration declined on Tuesday to approve neffy, an epinephrine nasal spray from drugmaker ARS Pharmaceuticals, keeping the first needle-free option for Americans to treat severe allergic reactions off the market pending more trial data.ARS had expected the FDA to approve neffy for use in adults and children who weigh more than 30 kilograms, or around 66 pounds. The spray would have required a prescription, similar to... + full article
RTTNews USA Health October 06, 2023
Biopharmaceutical company ARS Pharmaceuticals, Inc. () announced Friday that the U.S. Food and Drug Administration (FDA) has scheduled a Type A meeting to discuss the contents of a Complete Response Letter (CRL) previously issued regarding its new drug application (NDA) for... + más
First epinephrine nasal spray clears key FDA hurdle, promising needle-free alternative | CBS News
FDA rejects neffy epinephrine nasal spray for severe allergic reactions pending further trial data | CBS News
WPTV USA Nation September 20, 2023
Federal regulators called for additional study of Neffy, a nasal spray that could provide an alternative to EpiPens for type 1 allergic reactions, surprising its maker ARS Pharmaceuticals on Wednesday. ARS said the Food and Drug Administration requested a... + más
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The Boston Globe USA Opinion August 03, 2023
I was in seat 20C on a flight home in March when I felt my throat closing. Minutes earlier, hives had appeared on my face and chest. As a physician, I knew exactly what these symptoms meant: anaphylaxis, a severe allergic reaction so precipitously fatal that putting a breathing... + más
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The Hill USA Health May 15, 2023
A Food and Drug Administration (FDA) advisory panel an epinephrine nasal spray, clearing a hurdle for the product designed to help those with severe, potentially life-threatening allergic reactions. The panel, the Pulmonary-Allergy Drugs Advisory Committee, voted on Thursday... + más
In-flight emergencies raise concerns about airlines' medical kit requirements | CBS News
CBS News USA Politics May 12, 2023
A committee of the Food and Drug Administration's outside advisers voted Thursday in favor of an epinephrine nasal spray product, clearing a key hurdle for what could soon be the first needle-free option for treating severe allergic reactions.The majority backing the spray... + más
Doctor calling for FAA, Southwest changes after midair scare | ABC News
ABC News USA Life May 06, 2023
Following a mid-air scare, a doctor is calling for the Federal Aviation Administration to make policy changes and for Southwest Airlines to stock lifesaving epinephrine auto-injectors aboard passenger planes.Lindsey Ulin, an internal medicine resident physician at Brigham and... + más
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FAA says mobile home residents must move or Vero Beach will lose airport funding | WPTV
CBS News USA Nation December 10, 2022
Matt Luptak was flying with his 11-year-old daughter Sophia when her eyes started swelling and her airway began to close. I knew an EpiPen was what I needed, Luptak said. The flight attendant tells me, 'We don't have those.' Commercial airlines by the Federal... + más
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