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256 articles found
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FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating VariantsToday, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component th... -
FDA Roundup: August 20, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA approved Lazcluze (lazertinib) in combination with amivantamab for...
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FDA Marketing Authorization Enables Increased Access to First Step of Syphilis DiagnosisToday, the U.S. Food and Drug Administration granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. This is the first at-home, over-the-counter test to detect Treponema...
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FDA Roundup: August 16, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued notice of a Warning Letter sent to AUSTROFOOD S.A.S. (Aus...
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FDA Issues Warning Letter to Austrofood and Continues Robust Activities to Ensure Safety of Cinnamon Products Sold in U.S.Last fall, the U.S. Food and Drug Administration and our regulatory health partners at the North Carolina Department of Health and Human Services, the North Carolina Department of Agriculture & Consum...
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FDA Announces Milestone in Sodium Reduction Efforts, Issues Draft Guidance with Lower Target Levels for Certain FoodsImage Today, the U.S. Food...
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FDA Approves First Nasal Spray for Treatment of AnaphylaxisToday, the U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis...
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FDA Roundup: August 9, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA invites the public to register for the public meeting on the Developme...
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FDA Roundup: August 6, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA issued a Safety Alert advising restaurants and retailers not to se...
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FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial SarcomaThe U.S. Food and Drug Administration approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have receiv...