FDA Approvals-New Drugs, Diagnostics and Devices

AlloMap measures genetic information contained in the white blood cells (cells of the immune system that defend the body against invading viruses, bacteria or other foreign material) from a patient's blood sample.

The condition, which usually develops in adults, is known as chronic immune thrombocytopenic purpura (ITP), a disease that results in a low number of platelets...

Xenazine is a new drug and is the first treatment of any kind approved in the United States for any symptom of Huntington's disease. Currently there are no other drugs that are FDA-approved to treat chorea.

The Pathwork Tissue of Origin test compares the genetic material of a patient&8217;s tumor with genetic information on malignant tumor types stored in a database.

The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).

Device can help paralysis patients breathe without a ventilator for at least four hours

...approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery.

Only drug available in United States for irritable bowel syndrome with constipation

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.

Drug will help reduce effects of drugs like morphine on bowel function