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911 articles found
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FDA Roundup: August 23, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA’s Office of Global Policy and Strategy posted an article about the FD... -
FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine GummiesToday, the U.S. Food and Drug Administration issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product. These types of gummies are of...
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FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood TransfusionsToday, the U.S. Food and Drug Administration approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who...
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FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of AmericansToday, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of ov...
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FDA Roundup: August 12, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted a safety communication to provide information to blood establi...
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FDA Infant Formula Update: August 5, 2022Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased fle...
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FDA Approves First Targeted Therapy for HER2-Low Breast CancerToday, the U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (sp...
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FDA Roundup: August 5, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA cautioned pet owners not to feed their pets certain lots of Darwin’s...
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FDA Continues Efforts to Support Innovation in Medical Device SterilizationThe sterilization of medical devices is a vital process for helping to prevent serious infections. The U.S. Food and Drug Administration continually works to oversee sterilization methods for these de...
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FDA Roundup: August 2, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA announced the approval of the first generic firocoxib tablets for...