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911 articles found
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FDA Approves First Gene Therapy for Children with Metachromatic LeukodystrophyToday, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantil... -
FDA Roundup: March 15, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published its new paper, “Artificial Intelligence and Medical Products:...
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FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver DiseaseToday, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring...
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FDA Roundup: March 12, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance Select Updates for the Premarket Cybersecurity...
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FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public HealthToday, the U.S. Food and Drug Administration (FDA) announced it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency to enhan...
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FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or OverweightToday, the U.S. Food and Drug Administration approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with car...
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FDA Roundup: March 8, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced proposed new regulations to provide animal drug sponsors with...
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FDA, Industry Actions End Sales of PFAS Used in US Food PackagingToday, the U.S. Food and Drug Administration is announcing that grease-proofing materials containing per- and polyfluoroalkyl substances (PFAS) are no longer being sold for use in food packaging in th...
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FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic MelanomaToday, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be remov...
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FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental ExposureToday, the U.S. Food and Drug Administration approved Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of aller...