(HealthDay)—Approval by the U.S. Food and Drug Administration does not necessarily mean that a medication or medical device has received a grueling trial by fire and has been proven safe beyond all doubt, ...
Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable outcome measures for a study, accounted for significant delays in the approval of new drugs by the Food and Drug Administration ...
The Food and Drug Administration has cleared a first-of-a-kind blood test that can help predict intellectual disabilities in infants by analyzing their genetic code.
A panel of Food and Drug Administration experts again opposed expanding use of Johnson & Johnson's blood thinner Xarelto to reduce dangerous blood clots in a new group of patients, those with acute coronary artery disease.
The federal government has sent letters to states and other stakeholders across the country calling on them to encourage compounding pharmacies to register as a producer of sterile drugs in an effort to protect the public.
The U.S. Food and Drug Administration on Wednesday approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca that uses a novel approach to reduce blood sugar.
China's health authorities have found no link between a hepatitis B vaccine and the deaths of 17 children shortly after they were immunised, state media reported Friday.
French drug giant Sanofi announced Monday US health authorities had rejected its Lemtrada drug for some forms of multiple sclerosis, which is already approved in the European Union, Canada and Australia.
Vending machines will display calorie counts for each item along with the cost under new labeling regulations required under the federal health care overhaul law.
Ariad Pharmaceuticals has received approval to relaunch its leukemia drug Iclusig after addressing safety concerns raised by U.S. regulators in October.
The Food and Drug Administration will delay sweeping food safety rules proposed earlier this year and revise them to better accommodate farmers and businesses who would be affected.
The nutritional value of food and drinks advertised on children's television programs is worse than food shown in ads during general air time, according to University of Illinois at Chicago researchers.
The Food and Drug Administration is warning that a stimulant used in treatments for the childhood condition attention deficit-hyperactivity disorder can trigger painful, long-lasting erections in rare cases.
Treatment with the diabetes drug metformin appears to be associated with a modest reduction in body mass index (BMI) in obese children when combined with lifestyle interventions such as diet and exercise, according to a study ...
Princeton University officials say more than 90 percent of the eligible students and staff received a meningitis vaccine this week as part of the university's effort to halt an outbreak.