FDA Press Releases RSS Feed http://www.fda.gov/ en FDA Roundup: December 5, 2023 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 FDA, USDA and EPA Propose National Strategy to Reduce U.S. Food Loss and Waste 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 FDA Roundup: December 1, 2023 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 FDA Roundup: November 28, 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 FDA Cautions Public of Safety Issue with Philips’ DreamStation 2 CPAP Machines 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 FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors 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 FDA Roundup: November 21, 2023 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 FDA Roundup: November 17, 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 Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature Products 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 FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with at-home Sample Collection 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 Federal Court Enters Consent Decree Against Arizona-based Company for Distribution of Unapproved Contraceptive Drugs 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 FDA Roundup: November 14, 2023 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 FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus 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 FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder 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 FDA Clears First COVID-19 Home Antigen Test 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 FDA Approves New Medication for Chronic Weight Management 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 FDA Roundup: November 7, 2023 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 FDA Roundup: November 3, 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 National Survey Shows Drop in E-Cigarette Use Among High School Students 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 FDA Proposes to Ban Food Additive, Continues Assessments of Additional Chemicals 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