The FDA amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age.
Source: FDA Press Releases
Category Archives: FDA Press Releases
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Source: FDA Press Releases
FDA Commissioner Robert Califf confirms receipt and outlines next steps of the external evaluation conducted by the Reagan-Udall Foundation which includes an assessment of the processes and procedures, resourcing, and organizational structure for the Human Foods program.
Source: FDA Press Releases
FDA approves the first fecal microbiota product, Rebyota. Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. It is for used after an individual has completed antibiotic treatment for recurrent CDI.
Source: FDA Press Releases
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Source: FDA Press Releases
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Source: FDA Press Releases
FDA approves Hemgenix, an adeno-associated virus vector-based gene therapy indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency)
Source: FDA Press Releases
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency
Source: FDA Press Releases
Today, the FDA approved a new drug to delay the onset of stage 3 type 1 diabetes in adults and children 8 years and older who currently have stage 2 type 1 diabetes.
Source: FDA Press Releases
Today, the U.S. Food and Drug Administration issued warning letters to seven companies for selling dietary supplements claiming to cure, treat, mitigate, or prevent cardiovascular disease or related conditions.
Source: FDA Press Releases