FDA

The Food and Drug Administration (FDA) has permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of...

The Food and Drug Administration (FDA) announces it has cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually-transmitted infections, respectively...

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...

FDA commissioner Scott Gottlieb, MD, and director of FDA’s Center for Biologics Evaluation and Research Peter Marks, MD, PhD, have issued the following statement on efforts to promote and foster blood pathogen reduction technologies...

Today, the Food and Drug Administration (FDA) issued a letter to healthcare providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use 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...