http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-roundup-december-5-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 05 Dec 2023 16:59:37 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-december-5-2023 http://www.fda.gov/news-events/press-announcements/fda-usda-and-epa-propose-national-strategy-reduce-us-food-loss-and-waste FDA, USDA and EPA release draft strategy to prevent the loss and waste of food and increase recycling of organics to support a circular economy for all, reduce greenhouse gas emissions, save households and businesses money, and build cleaner communities Mon, 04 Dec 2023 09:04:50 EST FDA http://www.fda.gov/news-events/press-announcements/fda-usda-and-epa-propose-national-strategy-reduce-us-food-loss-and-waste http://www.fda.gov/news-events/press-announcements/fda-roundup-december-1-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 01 Dec 2023 16:46:57 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-december-1-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-november-28-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 28 Nov 2023 16:24:59 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-november-28-2023 http://www.fda.gov/news-events/press-announcements/fda-cautions-public-safety-issue-philips-dreamstation-2-cpap-machines The FDA is alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics’ DreamStation 2 Continuous Positive Airway Pressure (CPAP) machines used for treatment of obstructive sleep apnea Tue, 28 Nov 2023 15:36:57 EST FDA http://www.fda.gov/news-events/press-announcements/fda-cautions-public-safety-issue-philips-dreamstation-2-cpap-machines http://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-rare-type-non-cancerous-tumors The FDA approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Nirogacestat is a new molecular entity and the first drug to be approved for the treatment of patients with desmoid tumors, a subtype of soft tissue sarcomas. Mon, 27 Nov 2023 17:32:36 EST FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-rare-type-non-cancerous-tumors http://www.fda.gov/news-events/press-announcements/fda-roundup-november-21-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 21 Nov 2023 15:51:25 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-november-21-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-november-17-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 17 Nov 2023 16:18:18 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-november-17-2023 http://www.fda.gov/news-events/press-announcements/federal-judge-enters-consent-decrees-against-utah-based-dietary-supplement-distributor-and A dietary supplement distributor, dietary supplement manufacturer, and two executives have been ordered by a federal court to stop selling Balance of Nature products Thu, 16 Nov 2023 10:36:25 EST FDA http://www.fda.gov/news-events/press-announcements/federal-judge-enters-consent-decrees-against-utah-based-dietary-supplement-distributor-and http://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection Today, the FDA granted marketing authorization of first diagnostic test for chlamydia and gonorrhea with at-home sample collection. Wed, 15 Nov 2023 15:46:28 EST FDA http://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-arizona-based-company-distribution-unapproved The U.S. District Court for the District of Arizona entered a consent decree of permanent injunction ordering Smart Women’s Choice, Inc., an Arizona-based company. Wed, 15 Nov 2023 15:23:36 EST FDA http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-arizona-based-company-distribution-unapproved http://www.fda.gov/news-events/press-announcements/fda-roundup-november-14-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 14 Nov 2023 15:24:57 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-november-14-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-prevent-disease-caused-chikungunya-virus The FDA approved Ixchiq, the first vaccine for prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. Thu, 09 Nov 2023 16:59:30 EST FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-prevent-disease-caused-chikungunya-virus http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-rare-inherited-blood-clotting-disorder The FDA approved Adzynma, the first genetically engineered protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura, a rare and life-threatening blood clotting disorder. Thu, 09 Nov 2023 14:28:57 EST FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-rare-inherited-blood-clotting-disorder http://www.fda.gov/news-events/press-announcements/fda-clears-first-covid-19-home-antigen-test The FDA cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway. Thu, 09 Nov 2023 14:06:10 EST FDA http://www.fda.gov/news-events/press-announcements/fda-clears-first-covid-19-home-antigen-test http://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management The FDA approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition, for use in addition to a reduced calorie diet and increased physical activity. Wed, 08 Nov 2023 12:11:00 EST FDA http://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management http://www.fda.gov/news-events/press-announcements/fda-roundup-november-7-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 07 Nov 2023 15:38:09 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-november-7-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-november-3-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 03 Nov 2023 15:05:45 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-november-3-2023 http://www.fda.gov/news-events/press-announcements/national-survey-shows-drop-e-cigarette-use-among-high-school-students Today, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC), released federal data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. Thu, 02 Nov 2023 13:47:48 EDT FDA http://www.fda.gov/news-events/press-announcements/national-survey-shows-drop-e-cigarette-use-among-high-school-students http://www.fda.gov/news-events/press-announcements/fda-proposes-ban-food-additive-continues-assessments-additional-chemicals The FDA proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. The agency concluded that the use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health (NIH) found the potent Thu, 02 Nov 2023 10:01:46 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-proposes-ban-food-additive-continues-assessments-additional-chemicals