LabCorp Illegally Marketing Ovarian Cancer Test Without FDA Approval, Agency Says (Medical News Today)
FDA has sent a warning letter to Laboratory Corporation of America informing the company that it is illegally marketing a blood test to detect ovarian cancer in its early stages without agency approval, the New York Times reports. The $220 test, called OvaSure, was released in June under a rule that exempts tests from FDA regulation that are developed and marketed by a single company.

FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment For Routine Prophylaxis In Children With Hemophilia A (Medical News Today)
Bayer HealthCare LLC announced that the U.S. Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate(R) FS Antihemophilic Factor (Recombinant) to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged 0-16 years with severe hemophilia A with no pre-existing joint damage.

Theravance Announces FDA Advisory Committee to Review Telavancin for the Treatment of Complicated Skin and Skin ... (Marketwire via Yahoo! Finance)
Theravance, Inc. announced today that the Anti-Infective Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) will convene to review the New Drug Application for telavancin, a novel, bactericidal, once-daily injectable investigational antibiotic, for the proposed indication to treat complicated skin and skin structure infections caused by Gram-positive bacteria, including ...