January 16, 2014

The Food and Drug Administration on Thursday issued a warning that some cryogenic wart removers — which remove warts from the skin by freezing them off — have caught fire during use at home, harming consumers or setting fire to items around the house.

January 16, 2014

The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

January 15, 2014

A new drug for autoimmune diseases from Antares Pharma that the company calls the first of its kind is now available, the drug maker said Wednesday.

January 15, 2014

The Food and Drug Administration earlier this week issued final guidance for the industry on distinguishing liquid dietary supplements from beverages.

January 15, 2014

The Food and Drug Administration recommended healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit.

January 13, 2014

The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.

January 10, 2014

The Nonprescription Drugs Advisory Committee announced it would meet February 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA.

January 10, 2014

The Food and Drug Administration has approved two drugs made by GlaxoSmithKline for use together in patients with advanced melanoma that can't be removed by surgery or has spread to other parts of the body, the agency said Friday.

January 10, 2014

The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.

January 10, 2014

The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

January 9, 2014

Mylan has launched a generic drug for preventing rejection of transplanted organs, the company said Thursday.

January 8, 2014

Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

January 8, 2014

The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said.

January 8, 2014

Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

January 7, 2014

The Consumer Healthcare Products Association reported the makers of over-the-counter pediatric liquid medications have made significant progress in carrying out voluntary efforts to promote safe use through standardized dosing directions and dosing devices, as underscored by the results of a Centers for Disease Control and Prevention study released Monday in Pediatrics.

January 2, 2014

The Food and Drug Administration is cracking down on companies claiming their products can speed recovery from concussions, according to a consumer update posted Wednesday.

January 2, 2014

The number of new drugs approved by the Food and Drug Administration fell by more than 30% in 2013 compared with 2012, according to agency records.

January 2, 2014

PureCircle, a producer and marketer of stevia, announced that the Food and Drug Administration has approved PureCircle's Rebaudioside M (Reb M) as a general purpose sweetener for foods and beverages in the United States.

December 30, 2013

The Food and Drug Administration has declined to approve a drug made by Genzyme Corp. for certain forms of multiple sclerosis, the company said Monday.

December 27, 2013

The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

December 26, 2013

The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.

December 26, 2013

Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.

December 26, 2013

The Food and Drug Administration has postponed the time it will decide whether or not to approve an experimental treatment under development by Takeda Pharmaceutical Co. for ulcerative colitis, the company said.

December 26, 2013

Sales of OTC female contraceptives ought to be significant in the coming year.