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 The U.S. Food and Drug Administration (FDA) has released a draft guidance that provides updated…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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FDA Approves Nasal Spray for Emergency Overdose Treatment
Opvee nasal spray addresses respiratory depression, sedation, and low blood pressure. The U.S. Food and Drug Administration (FDA) has given its approval for Opvee—the first nasal spray containing…
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FDA Grants Full Approval for COVID-19 Pill Paxlovid
Pfizer is authorized to sell the drug in the United States. The Food and Drug Administration (FDA) has granted Pfizer’s drug Paxlovid full authorization for use in the…
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White House Seeks Increased Access to Overdose-Reversal Drug
Officials will talk with manufacturers to reduce the cost of naloxone. A spokesperson for the White House Office of National Drug Control Policy (ONDCP) recently said that President…
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