The joint effort by federal agencies seeks to protect consumers from the potentially harmful ingredient. The Federal Trade Commissioner (FTC) and the Food and Drug Administration (FDA) have…
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FDA Fully Approves Alzheimer’s Drug Leqembi
This traditional approval follows previously fast-tracked authorization. The Food and Drug Administration (FDA) has approved Leqembi for the treatment of Alzheimer’s disease. The FDA included a safety warning…
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FDA Approves First Cell Therapy for Type 1 Diabetes
The treatment was developed to address patients struggling to maintain target blood glucose levels. The U.S. Food and Drug Administration recently granted approval to CellTrans, Inc. for Lantidra.…
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FDA Approves Gene Therapy for Muscular Dystrophy in Children
Treatment is intended for kids with a confirmed mutation of the DMD gene. The U.S. Food and Drug Administration (FDA) recently approved Elevidys, the first gene therapy for…
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U.S. Military Adds Blue Lotus to Banned Substance List
FDA does not regulate the psychotropic drug, available via e-cigarettes or vaping. The Department of Defense has added blue lotus, a drug from the Egyptian flower Nymphaea caerulea,…
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USDA Approves Lab-Grown Chicken Meat
FDA already authorized products as safe to consume. The U.S. Department of Agriculture’s Food Safety and Inspection Service has given the approval for a meat product grown directly…
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FDA Releases Guidelines on Safeguarding Tattoo Ink from Microbes
The guidance is open to public comment for 90 days. The U.S. Food and Drug Administration (FDA) has released preliminary guidelines to help tattoo ink manufacturers and distributors…
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FDA Proposes Updates to Clinical Trials
The drafted guidance would modernize the trials to be more efficient and reliable. The U.S. Food and Drug Administration (FDA) has released a draft guidance that provides updated…
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FDA Addresses Retailers Selling E-Cigarettes to Youth
Letters follow an investigation into the sale of unauthorized products. The U.S. Food and Drug Administration (FDA) sent warning letters to 30 retailers and one distributor, following an…
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FDA Proposes Easy-to-Read Medication Guides
Agency seeks to prevent adverse drug reactions and improve health outcomes. The U.S. Food and Drug Administration (FDA) has proposed that patients be provided an easy-to-read one-page guide,…
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