Theravance Announces FDA Acceptance of Telavancin NDA (Market Wire via Yahoo! Finance)
Theravance, Inc. announced today that the U.S. Food & Drug Administration has accepted the New Drug Application for its investigational antibiotic telavancin for the treatment of complicated skin and skin structure infections caused by Gram-positive organisms, including methicillin-resistant Staphylococcus aureus. The FDA has established a goal of a standard ten-month review of the telavancin ...

St. Jude Medical Receives FDA Clearance for Venture Catheter with New Delivery Platform (Business Wire via Yahoo! Finance)
ST. PAUL, Minn.----St. Jude Medical, Inc. today announced U.S. Food and Drug Administration clearance for the Venture Wire Control Catheter on a rapid exchange delivery platform, a delivery design that accommodates shorter guidewires and may result in quicker, easier coronary procedures.

Edwards Lifesciences gets FDA warning (Orange County Register)
The company says concerns about quality systems issues are being addressed. Edwards Lifesciences Corp ., the Irvine heart valve company, said today it received a warning letter from the U.S. Food and Drug Administration over quality systems issues.