FDA Approvals-New Drugs, Diagnostics and Devices

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Huntington's Disease: FDA Approves First Drug for Treatment of Chorea in Huntington's Disease

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.

Date: 08/15/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01874.html

FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample

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.

Date: 07/31/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01870.html

Breast Cancer: FDA Approves New Genetic Test for Patients with Breast Cancer

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).

Date: 07/08/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01857.html

Breathing Control-FDA Approves Diaphragm-Pacing Device

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

Date: 06/18/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01853.html

Bowel Function: FDA Approves Entereg to Help Restore Bowel Function Following Surgery

...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.

Date: 05/21/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01838.html

IBS-Irritable Bowel Syndrome: FDA Approves Amitiza for IBS-C

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

Date: 04/29/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01828.html

Coronary Artery Plaque Imaging Device Cleared by FDA

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.

Date: 04/29/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01827.html

Constipation: FDA Approves Relistor for Opioid-Induced Constipation

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

Date: 04/24/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01826.html

Latex: FDA Clears Glove Made from New Type of Latex

...from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States

Date: 04/23/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01822.html

Crohn's Disease: FDA Approves Cimzia to Treat Crohn's Disease

Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies...

Date: 04/22/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01821.html

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