Peggy Peck





FDA Approves Drug for Breast Cancer Resistant to First-Line Treatments

October 17, 2007

ROCKVILLE, Md. -- Bristol-Myers Squibb said its metastatic breast cancer drug ixabepilone (Ixempra) has received FDA approval for treatment of women with metastatic or locally advanced treatment-resistant breast cancer.

FDA Approves Oral Agent for Relapsed Small-Cell Lung Cancer

October 16, 2007

PHILADELPHIA -- The FDA has approved topotecan (Hycamtin) capsules for treatment of relapsed small-cell lung cancer, GlaxoSmithKline has announced.

FDA Wants Pancreatitis Caution Added to Exenatide (Byetta) Label

October 16, 2007

ROCKVILLE, Md. -- The FDA said today it has received 30 reports of acute pancreatitis in patients taking exenatide (Byetta) for treatment of type 2 diabetes.

Faulty ICD Leads Spur Move by Medtronic to Stop Selling Devices

October 15, 2007

ROCKVILLE, Md. -- Fractures of Sprint Fidelis defibrillator leads have triggered a voluntary move by Medtronic to stop selling them, a decision that was promptly endorsed by the FDA.

Colorectal Cancer Leads Decline in Cancer Death Rates

October 15, 2007

Cancer death rates fell by about 2.1% per year from 2002 to 2004, compared with a 1.1% per year decline from 1993 though 2002, according to annual report to the nation from the Centers for Disease Control and Prevention, the American Cancer Society, the National Cancer Institute, and the North american Association of Central Cancer Registries.

FDA Approves First-in-Class Integrase Inhibitor for Treatment-Resistant HIV-1

October 15, 2007

WHITEHOUSE STATION, N.J. -- The FDA has approved raltegravir (Isentress) as part of a combination regiment for treatment for multi-resistant HIV-1 infection in adults, according to an announcement from Merck.

FDA Advisers Unanimously Urge Approval of New Drug-Eluting Stent

October 11, 2007

GAITHERSBURG, Md. -- An FDA advisory panel voted unanimously to recommend approval of a zotarolimus-eluting coronary stent made by Medtronic.

Two Deaths Prompt FDA Meningitis Alert on Cochlear Implants

October 11, 2007

ROCKVILLE, Md. -- The FDA has alerted physicians to the need for children with cochlear implants to be fully immunized against bacterial meningitis, citing two recent deaths that might have been prevented.