For Immediate Release: October 11, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA has issued an immediately-in-effect guidance, Temporary Policies for Compounding …
FDA News Release Product is First Non-Factor and Once-Weekly Treatment for Hemophilia B For Immediate Release: October 11, 2024 Today, the U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce …
For Immediate Release: September 27, 2024 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 updated the Mycotoxins in Domestic and Imported Human Foods Compliance Program …
For Immediate Release: September 26, 2024 Today, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to …
For Immediate Release: September 24, 2024 Today, the U.S. Food and Drug Administration approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients …
For Immediate Release: September 24, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA held a ribbon-cutting ceremony to highlight the completion of the 64,000 square foot …
For Immediate Release: September 20, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA and NIH announced “Advancing Smoking Cessation: FDA and NIH Priorities” – a joint …
FDA News Release First Influenza Vaccine That Does Not Need to be Administered by a Health Care Provider For Immediate Release: September 20, 2024 Today, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist …
For Immediate Release: September 20, 2024 Today, the U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat …
For Immediate Release: September 17, 2024 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and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and …
For Immediate Release: September 16, 2024 Today, the U.S. Food and Drug Administration issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials (MRCT) in support of …
For Immediate Release: September 13, 2024 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 published the FDA Voices: “Join FDA for the First National Hispanic/Latino …
For Immediate Release: September 12, 2024 Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro …
FDA News Release Firms Provided Third-Party, Nonclinical Premarket Testing; Agency Review Ongoing For Immediate Release: September 11, 2024 Today, the U.S. Food and Drug Administration issued warning letters to two Chinese nonclinical testing laboratories, …
For Immediate Release: September 10, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted a warning letter issued to Root Bioscience Brands LLC, doing business as …
For Immediate Release: August 30, 2024 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: August 30, 2024 Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better …
FDA News Release Tobacco Retailers Will Need to Verify Age for Anyone Under 30; Vending Machine Sales Will Be Restricted to 21+ Facilities For Immediate Release: August 29, 2024 Today, the U.S. Food and Drug Administration announced a final rule that …
For Immediate Release: August 27, 2024 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 revised the Emergency Use Authorization for Pemgarda (pemivibart) to limit its use to …
FDA News Release Agency Supports Broader Access to Innovative Technology in Diabetes Management For Immediate Release: August 26, 2024 Today, the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an …
