FDA Approvals - St. Jude Medical Announces FDA Approval of Atlas II ICD
St. Jude Medical Announces FDA Approval of Atlas II ICD and Atlas II Heart Failure Devices (Business Wire via Yahoo! Finance)
ST. PAUL, Minn.----July 18, 2006--St. Jude Medical, Inc. today announced U.S. Food and Drug Administration approval of new, powerful devices for treating patients with potentially lethal heart arrhythmias and heart failure.
Nastech Pharmaceutical Company Receives FDA Communication Concerning Calcitonin-Salmon Nasal Spray (Medical News Today)
NastechPharmaceutical Company Inc. (Nasdaq: NSTK) announced today that writtennotification from the FDA was received on July 10, 2006 stating thatNastech's abbreviated new drug application (ANDA) for intranasalcalcitonin-salmon is not approvable at this time. In a subsequentconference call on July 11, 2006, Nastech reviewed the status of the ANDAwith the FDA. [click link for full article]
Cambrex and Ortec Submit to FDA a Humanitarian Device Exemption (HDE) for OrCel(R) to Treat Epidermolysis Bullosa (RedNova)
WALKERSVILLE, Md., and NEW YORK, July 17 /PRNewswire-FirstCall/ -- Cambrex Bio Science Walkersville, Inc., a subsidiary of Cambrex Corporation , and Ortec International, Inc.