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 …
For Immediate Release: December 05, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, registration opened for the FDA’s virtual Rare Disease Day on Friday, March 1, 2024. This year …
For Immediate Release: May 11, 2023 Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the …
For Immediate Release: May 11, 2023 Today, the U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These …
For Immediate Release: May 09, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA granted marketing authorization of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 …
For Immediate Release: July 05, 2023 Today, the U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to six companies for illegally selling copycat food products containing Delta-8 tetrahydrocannabinol, also known as …
For Immediate Release: May 05, 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 a safety communication to warn consumers and health care providers to stop …
For Immediate Release: April 28, 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 issued a final guidance for industry titled Smoking Cessation and Related Indications: …
For Immediate Release: April 26, 2023 Today, the U.S. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) …
