October 5, 2011

The Food and Drug Administration has accepted a regulatory approval application from Merck and Ariad Pharmaceuticals for a new drug to treat soft-tissue and bone cancers, the drug makers said Wednesday.

October 4, 2011

Amneal last month launched its version of an epilepsy treatment.

October 4, 2011

The Food and Drug Administration has launched an initiative that is designed to assure the safety of food sold at retail.

October 4, 2011

Insomnnia may be the next big treatment regimen to make a switch from prescription-only to over the counter.

October 4, 2011

Sun Pharmaceutical Industries last month said that it has resolved issues cited in a warning letter sent to the company by the Food and Drug Administration pertaining to one of Sun Pharma's U.S.-based manufacturing facilities.

October 4, 2011

The Medicines Co. and generic drug maker Teva Pharmaceutical Industries have reached a settlement that will allow Teva to start selling a generic version of one of MDCO's drugs by the end of the decade.

October 3, 2011

The Food and Drug Administration has approved a generic antibiotic made by Sagent Pharmaceuticals, Sagent said.

September 30, 2011

Novo Nordisk is seeking approval for two new insulin products, the company said Thursday.

September 30, 2011

A fifth dietary supplement trade association may be in the early formulation stages, specifically designed to address the Food and Drug Administration's recent issues of New Dietary Ingredient guidance, according to a Nutrition Business Journal report published Wednesday.

September 30, 2011

The New Dietary Ingredient draft guidance, which recently was issued by the Food and Drug Administration, is causing a stir within the dietary supplement industry as experts continue to evaluate what kind of impact the guidance will have on their businesses.

September 29, 2011

The Food and Drug Administration has declined to approve a vaccine developed by GlaxoSmithKline, the drug maker said.

September 29, 2011

Last year, U.S. Customs and Border Protection seized $5.6 million worth of illegal pharmaceutical products, a 170% increase over 2005. Meanwhile, global sales of counterfeit medicines were estimated to be more than $75 billion last year, 90% more than in 2005. In response, Pfizer and the National Association of Boards of Pharmacy announced Thursday the launch of an effort to educate patients on how to safely buy medicines online and about the risks of counterfeit drugs.

September 29, 2011

Roche has received approval from the Food and Drug Administration for its new generation of blood-glucose test strips.

September 28, 2011

Chelsea Therapeutics International has applied for Food and Drug Administration approval of a drug for a disorder that affects patients with diseases like Parkinson's disease.

September 27, 2011

Lannett has received regulatory approval from the Food and Drug Administration for its version of an antipsychotic treatment.

September 26, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis in children.

September 23, 2011

The Food and Drug Administration has approved a treatment made by Alexion Pharmaceuticals for a rare blood disorder that affects children.

September 22, 2011

Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

September 22, 2011

Epinephrine inhalers will not be made or sold after Dec. 31, and patients using them should get new prescriptions to replace them, the Food and Drug Administration said Thursday.

September 21, 2011

Researchers at the University of California Los Angeles said they have found a possible link between two new drugs for Type 2 diabetes and cancers of the pancreas and thyroid, according to a new study published in the journal Gastroenterology.

September 20, 2011

Mylan subsidiary Matrix Labs has received tentative approval from the Food and Drug Administration for its new drug application of a co-packaged antiretroviral treatment under the President's Emergency Plan for AIDS Relief.

September 20, 2011

The Food and Drug Administration has approved a generic version of a deep vein thrombosis treatment.

September 19, 2011

The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

September 15, 2011

The Food and Drug Administration has approved a generic drug for epilepsy made by Lupin Pharmaceuticals, the drug maker said.