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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FDA Issues Alert on Safety Concerns with Certain CPAP Machines
Reports of thermal issues with Philips DreamStation 2 CPAP Machines prompt discussions with the company. The U.S. Food and Drug Administration (FDA) has alerted patients and healthcare providers…
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FDA Approves Treatment for Rare Tumors
Though noncancerous, the tumors can decrease quality of life. The U.S. Food and Drug Administration (FDA) recently approved Ogsiveo (nirogacestat) tablets as the first-ever treatment for desmoid tumors—a…
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Federal Agencies Announce Food Waste Strategy at COP28 Summit
Collaborative agency effort is intended to build resilient food systems. The U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA) jointly announced…
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White House Seeks More RSV Vaccine Doses
A meeting was held between administration officials and drug manufacturers. White House senior officials met with prominent drug manufacturers this past week, to strategize how to increase the…
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FDA Approves New Treatment for Rare Blood Clotting Disorder
Director Marks announced the therapy for the life-threatening disorder. The U.S. Food and Drug Administration recently approved Adzynma for patients with congenital thrombotic thrombocytopenic purpura (cTTP). The genetically…
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