Approval provides early access to therapy while clinical trials continue. The U.S. Food and Drug Administration (FDA) recently approved Amtagvi (lifileucel) as the first cellular therapy for adults…
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FDA Finding Prompts Recall of Eye Ointment Products
The agency reported one of the products lacked the assurance of sterility. The Food and Drug Administration (FDA) issued an announcement this week that four types of eye…
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FDA Approves Xolair for Food Allergy Treatment
Associate Director Stone says the injection, while not a cure, “will help reduce the health impact if accidental exposure occurs.“ U.S. Food and Drug Administration (FDA) has approved…
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FDA Approves Treatment for Severe Frostbite
The injections are intended to prevent amputation of digits. The Food and Drug Administration approved a new treatment for severe frostbite this week that is intended to prevent…
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CDC Issues Alert on Listeria Outbreak
The food safety alert includes certain queso fresco and cotija cheese. The Centers for Disease Control and Prevention (CDC) released an alert regarding the outbreak of listeria in…
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Senator Schumer Urges FDA and FTC to Further Regulate Nicotine Pouches
He calls Zyn product “quiet and dangerous.“ Senate Majority Leader Chuck Schumer of New York has called for the Food and Drug Administration and the Federal Trade Commission…
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FDA Recognizes Hydrogen Peroxide for Sterilization of Medical Devices
The agency supports the broader adoption of vaporized peroxide as an alternative to sterilizing with ethylene oxide. The U.S. Food and Drug Administration (FDA) announced that vaporized hydrogen…
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FDA to Update CISA Protocols on Medical Devices
GAO reports the agency’s cyber security agreement is five years old. The Government Accountability Office has reported that the Food and Drug Administration needs to work with the…
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Federal Court Issues Injunction Against Pharmaceutical Company
The corporation is prohibited from distributing drugs after not complying with federal manufacturing requirements. The District Court of Massachusetts brought a permanent injunction against Pharmasol Corporation, which is…
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FDA Approves Gene Therapies for Sickle Cell Disease
Two cell-based gene therapies will address the debilitating hereditary blood disorder. The U.S. Food and Drug Administration (FDA) has granted approval of two groundbreaking cell-based gene therapies, Casgevy…
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