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256 articles found
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FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting DisorderToday, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement th... -
FDA Clears First COVID-19 Home Antigen TestToday, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally author...
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FDA Approves New Medication for Chronic Weight ManagementToday, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) o...
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FDA Roundup: November 7, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA issued a Safety Communication warning consumers, health care provide...
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FDA Roundup: November 3, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA announced that its Center for Devices and Radiological Health (CDR...
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National Survey Shows Drop in E-Cigarette Use Among High School StudentsToday, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC), released data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S...
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FDA Proposes to Ban Food Additive, Continues Assessments of Additional ChemicalsToday, the U.S. Food and Drug Administration proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. The agency concluded that the intended use of BVO in food...
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FDA Roundup: October 27, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA Center for Tobacco Products (CTP) Director Brian King published a statem...
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FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm InfantsAs part of the U.S. Food and Drug Administration’s commitment to protecting public health, the agency is advising the public, including healthcare providers, of the possible risks that products contai...
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FDA Approves New Therapy for Rare Form of Blood Cancers Called Myelodysplastic SyndromesToday, the U.S. Food and Drug Administration approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehy...