For Immediate Release: June 09, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided information to health care providers and facilities on oxygenator devices used in …
For Immediate Release: July 06, 2023 Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial …
For Immediate Release: June 06, 2023 Today, 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 Letter to Health Care Providers recommending health care facilities and …
For Immediate Release: June 06, 2023 Español Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect …
FDA News Release Agency Requesting Feedback on the Draft Recommendations and How They Should Be Applied to Increasingly Diverse Trial Types and Data Sources For Immediate Release: June 06, 2023 Today, the U.S. Food and Drug Administration is announcing the …
For Immediate Release: May 31, 2023 Today, the U.S. Food and Drug Administration issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. The unauthorized products were various types of Puff …
For Immediate Release: May 30, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Related Information ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human …
For Immediate Release: May 30, 2023 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration Providing people with accurate and timely information to help them take their prescription medications safely and …
For Immediate Release: May 26, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued warning letters to firms responsible for two popular flavored, disposable e- …
For Immediate Release: May 25, 2023 Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at …
For Immediate Release: May 23, 2023 FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria Today, the U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment …
For Immediate Release: May 23, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA and the Veterans Health Administration announced a new collaboration to jointly develop …
For Immediate Release: May 23, 2023 Today, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available …
FDA News Release Nalmefene Hydrochloride Product in Nasal Spray Form Provides Additional Tool for Harm Reduction Groups and First Responders For Immediate Release: May 22, 2023 Today, the U.S. Food and Drug Administration approved Opvee, the first …
For Immediate Release: May 19, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced that the National Academies of Sciences, Engineering, and Medicine (NASEM) will …
For Immediate Release: May 19, 2023 Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic …
FDA News Release Agency Continues to Support Innovation of Next-Generation Technology in Diabetes Management For Immediate Release: May 19, 2023 Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing …
For Immediate Release: May 16, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated its new Rumor Control page to provide the facts and inform the public on how the …
For Immediate Release: May 12, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated information on medical device shortages on the FDA.gov website to reflect the end …
For Immediate Release: May 12, 2023 Today, the U.S. Food and Drug Administration 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 …
