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256 articles found
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FDA Roundup: March 26, 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 proposed a ban of electrical stimulation devices intended to reduce... -
FDA Roundup: March 22, 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 an emergency use authorization for Pemgarda (pemivibart) for the...
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FDA Roundup: March 19, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided an update on our evaluation of quality and performance issues r...
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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...
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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and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance Select Updates for the Premarket Cybersecurity...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...