http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-conducts-retailer-inspection-blitz-cracks-down-illegal-sales-popular-disposable-e-cigarettes The FDA issued warning letters to 29 retailers, and one distributor, for illegally selling unauthorized tobacco products, specifically types of Puff and Hyde disposable e-cigarettes. Wed, 31 May 2023 10:20:58 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-conducts-retailer-inspection-blitz-cracks-down-illegal-sales-popular-disposable-e-cigarettes http://www.fda.gov/news-events/press-announcements/fda-roundup-may-30-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 30 May 2023 16:02:55 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-30-2023 http://www.fda.gov/news-events/press-announcements/fda-proposes-new-easy-read-medication-guide-patients-patient-medication-information The FDA proposed a new, easy-to-read Medication Guide for patients. Patient Medication Information would provide patients with clear, concise, accessible and useful written information for prescription drugs and certain biological products would be delivered in a consistent and easy-to-understand fo Tue, 30 May 2023 11:40:32 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-proposes-new-easy-read-medication-guide-patients-patient-medication-information http://www.fda.gov/news-events/press-announcements/fda-roundup-may-26-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 26 May 2023 15:09:11 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-26-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults The FDA approved oral antiviral Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Thu, 25 May 2023 09:56:49 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria FDA approved Xacduro, a new treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. Tue, 23 May 2023 17:16:21 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria http://www.fda.gov/news-events/press-announcements/fda-roundup-may-23-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 23 May 2023 16:04:34 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-23-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-new-buprenorphine-treatment-option-opioid-use-disorder The U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use to treat moderate to severe opioid use disorder (OUD) Tue, 23 May 2023 15:32:53 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-new-buprenorphine-treatment-option-opioid-use-disorder http://www.fda.gov/news-events/press-announcements/fda-approves-prescription-nasal-spray-reverse-opioid-overdose The U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older Mon, 22 May 2023 16:56:52 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-prescription-nasal-spray-reverse-opioid-overdose http://www.fda.gov/news-events/press-announcements/fda-roundup-may-19-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 19 May 2023 15:31:46 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-19-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-topical-gene-therapy-treatment-wounds-patients-dystrophic-epidermolysis-bullosa FDA approves Vyjuvek, a herpes-simplex virus type 1 vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain gene. Fri, 19 May 2023 13:47:19 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-topical-gene-therapy-treatment-wounds-patients-dystrophic-epidermolysis-bullosa http://www.fda.gov/news-events/press-announcements/fda-clears-new-insulin-pump-and-algorithm-based-software-support-enhanced-automatic-insulin-delivery The U.S. Food and Drug Administration cleared devices that are part of the Beta Bionics iLet Bionic Pancreas System for people six years of age and older with type 1 diabetes Fri, 19 May 2023 11:32:59 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-clears-new-insulin-pump-and-algorithm-based-software-support-enhanced-automatic-insulin-delivery http://www.fda.gov/news-events/press-announcements/fda-roundup-may-16-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 16 May 2023 13:51:28 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-16-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-may-12-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 12 May 2023 15:32:09 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-12-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause The FDA approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. Fri, 12 May 2023 14:01:24 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause http://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-agitation-symptoms-associated-dementia-due-alzheimers-disease The FDA granted supplemental approval to Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication. Thu, 11 May 2023 09:29:10 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-agitation-symptoms-associated-dementia-due-alzheimers-disease http://www.fda.gov/news-events/press-announcements/fda-finalizes-move-recommend-individual-risk-assessment-determine-eligibility-blood-donations The FDA finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. Thu, 11 May 2023 08:53:17 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-finalizes-move-recommend-individual-risk-assessment-determine-eligibility-blood-donations http://www.fda.gov/news-events/press-announcements/fda-roundup-may-09-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 09 May 2023 14:42:03 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-09-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-may-05-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 05 May 2023 13:43:34 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-05-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine The FDA has approved Arexvy, the first RSV vaccine approved for use in the U.S. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. Wed, 03 May 2023 13:01:55 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine