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911 articles found
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FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune DisorderToday, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms (w... -
FDA Roundup: May 20, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On May 19, the FDA issued responses to two food additive petitions and a citizen petit...
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FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply ChainDrug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to...
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New FDA Draft Guidance Aims to Increase Safety Information About Dietary Supplement MarketplaceToday, the U.S. Food and Drug Administration announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace...
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FDA Roundup: May 17, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “FDA Seeks to Engage Stakeholders on Key Cons...
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Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 YearsToday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to...
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Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSVToday, the U.S. Food and Drug Administration authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infectio...
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FDA Roundup: May 13, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA advised consumers about the risk of accidental ingestion, especially by c...
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FDA Approves Novel, Dual-Targeted Treatment for Type 2 DiabetesToday, the U.S. Food and Drug Administration approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. Mounjaro was...
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FDA Roundup: May 10, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA approved a new indication for Olumiant (baricitinib) for the treatment of...