09/05/2012 - 11:43am

Bayer HealthCare and Onyx Pharmaceuticals are seeking approval for a new drug to treat tumors of the gut, the companies said.

09/05/2012 - 11:02am

The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug's manufacturer said.

09/05/2012 - 7:16am

The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.

09/04/2012 - 1:00pm

Generic drug maker Impax Labs has settled with a subsidiary of Sanofi regarding generic versions of two drugs for dialysis patients, Impax said Tuesday.

09/04/2012 - 12:40pm

The Food and Drug Administration has approved a generic antidepressant made by Wockhardt, the Indian drug maker said Tuesday.

09/04/2012 - 12:04pm

According to a Food and Drug Administration post Friday, the FDA's Nonprescription Drugs Advisory Committee will be meeting Nov. 9 regarding the partial switch application from prescription to over the counter of Oxytrol (oxybutynin transdermal system), as submitted by MSD Consumer.

09/04/2012 - 10:56am

The Food and Drug Administration has approved a new formulation of a cancer drug made by Novartis for a type of brain cancer in children, the agency said.

09/04/2012 - 10:49am

The Food and Drug Administration has approved a new drug made by Astellas Pharma U.S. and Medivation for treating prostate cancer, the agency said Friday.

08/30/2012 - 2:07pm

The Food and Drug Administration has approved a new drug for treating bowel diseases made by Ironwood Pharmaceuticals, the agency said Thursday.