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911 articles found
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FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-AdministrationToday, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A an... -
FDA Approves First Treatment for Niemann-Pick Disease, Type CToday, the U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhib...
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FDA Roundup: September 20, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA and NIH announced “Advancing Smoking Cessation: FDA and NIH Priorities...
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FDA Roundup: September 17, 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and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a draft guidance, “Integrating Randomized Controlled Trials for...
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FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in OncologyToday, the U.S. Food and Drug Administration issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials (MRCT) i...
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FDA Roundup: September 13, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA published the FDA Voices: “Join FDA for the First National Hispa...
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FDA Authorizes First Over-the-Counter Hearing Aid SoftwareToday, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple Air...
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FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab PracticesToday, the U.S. Food and Drug Administration issued warning letters to two Chinese nonclinical testing laboratories, citing both for laboratory oversight failures and animal care violations that raise...
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FDA Roundup: September 10, 2024Today, 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 warning letter issued to Root Bioscience Brands LLC, doing bu...
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Youth E-Cigarette Use Drops to Lowest Level in a DecadeHalf a million fewer U.S. youth reported current use of e-cigarettes in 2024 compared to 2023, according to new data from the National Youth Tobacco Survey (NYTS) released today by the U.S. Food and D...