The Food and Drug Administration (FDA) announces the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory...
Peter Marks, MD, PhD, director of the Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research, has issued the following statement on the agency's continued confidence in the safety and effectiveness of the measles, mumps...
The Food and Drug Administration (FDA) today issued a final rule designed to help ensure that hand sanitizers available over-the-counter (OTC) are safe and effective for those who rely on them. The rule establishes that certain active ingredients...
The Food and Drug Administration (FDA) today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and...
The Food and Drug Administration (FDA) announces it has permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to...
The following is a statement from Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data...
The Food and Drug Administration (FDA) announced its proposal to create a separate regulatory category for antiseptic products used in food handler settings...
