Roxro Pharma Inc. announced Friday that the U.S. Food and Drug Administration has accepted to review a new drug application for its anti-inflammatory nasal spray.

The US Food and Drug Administration announced that it is working with the maker of Xigris (drotrecogin alfa activated), Eli Lilly and Company, to further evaluate the incidence of serious bleeding events and death in patients who receive Xigris, a drug used to treat severe sepsis (a blood stream infection).

EpiCept Corporation announced that the US Food and Drug Administration (FDA) indicated that the company has the necessary pivotal data to file a New Drug Application (NDA) for Ceplene (histamine dihydrochloride) in conjunction...

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 that prasugrel, an investigational antiplatelet agent, should be approved for the treatment of patients with acute coronary syndromes (ACS) managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), Daiichi Sankyo Company, Limited, and Eli Lilly and Company announced.