The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.
A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said.
The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.
As if the reported spot shortages of flu vaccine aren't bad enough, there have been reports of similar shortages of flu drugs throughout the United States and parts of Canada due to increased demand.
An online plea for help from a mother dying of breast cancer prompted the manufacturer of an experimental drug to release it early, according to published reports.
Breast cancer patients taking an experimental drug made by Roche subsidiary Genentech lived significantly longer than those taking another drug made by GlaxoSmithKline, according to results of a late-stage clinical trial.
The Food and Drug Administration has approved Watson's generic version of a drug used to prevent and treat osteoporosis in post-menopausal women, the company said.
The FDA announced the approval of Genentech's Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.
A new report from the Food and Drug Administration indicated that Roche division Genentech may not have followed proper procedures to prevent the contamination of certain drugs, according to published reports.
The Food and Drug Administration has approved a new drug and companion diagnostic test for the most dangerous type of skin cancer, the agency said Wednesday.
An investigational treatment made by Roche for asthma increased lung function in patients who could not adequately control their disease with inhaled corticosteroids, according to results of a mid-stage clinical trial.