The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy ( PML ), a rare but serious brain infection, associated with use of Tysabri ( natalizumab ) for the treatment of multiple sclerosis (MS) and Crohn's disease.

The U.S. Food and Drug Administration (FDA) is reviewing data from a clinical trial that was evaluating the effects of the antiarrhythmic drug Multaq ( dronedarone ) in patients with permanent atrial fibrillation.

In January 2008, manufacturers voluntarily removed over-the-counter (OTC) infant (less than 2 years of age) cough and cold products from the market due to safety concerns. Later in fall of 2008, manufacturers also voluntarily relabeled these cough and cold products to state: “do not use in children under 4 years of age.” However, there are concerns that many parents may be giving cough and cold products that remain on the market - those designed for older children - to their infants. FDA reminds all caregivers never to give a child under two years of age any kind of cough and cold p...

The U.S. Food and Drug Administration today approved the blood-thinning drug Brilinta ( ticagrelor ) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).

The U.S. Food and Drug Administration (FDA) is continuing to review data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus (esophageal cancer).

The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.

The U.S. Food and Drug Administration (FDA) is informing the public of important product safety changes to the influenza drug Tamiflu ( oseltamivir phosphate) for oral suspension.

The U.S. Food and Drug Administration today approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.

The U.S. Food and Drug Administration (FDA) today approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals of modified recommendations for more conservative dosing of erythropoiesis-stimulating agents ( ESAs ) in patients with chronic kidney disease (CKD) to improve the safe use of these drugs.