The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.

The U.S. Food and Drug Administration on Thursday urged medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats that could compromise the devices or patient privacy.

After a busy two weeks of court rulings, the US Food and Drug Administration has finally come to an agreement with the federal courts concerning emergency contraception. But the product still isn’t on drugstore shelves and won’t be for at least another month.    

The Food and Drug Administration is warning makers of heart monitors, mammogram machines and myriad other medical devices that their gear is at risk of being infected with computer viruses that can endanger patients.

MUMBAI (Reuters) - Ranbaxy Laboratories, India's No.1 drugmaker by sales, plans to file three to four generic drug applications every year that can earn it a six-month marketing exclusivity in the United States, the company's chief executive said on Thursday. The first company that seeks approval from the U.S. Food and Drug Administration for a generic version of a patented ...