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Peggy Peck
Articles
Mortality in Phase III Trial Pulls Plug on HDL-Booster
December 04, 2006
CLEVELAND -- The abrupt halt to clinical trials of torcetrapib, an investigational HDL-boosting agent, raises questions about any drug that inhibit cholesteryl ester transfer protein (CETP), according to cardiologist Steven Nissen, M.D., of the Cleveland Clinic.
FDA Allows Return of Silicone-Gel Breast Implants
November 20, 2006
ROCKVILLE, Md. -- After a 14-year ban, silicone-gel breast implants will be allowed back on the market for breast reconstruction or augmentation, the FDA announced.
FDA Gives Herceptin Additional Breast Cancer Indication
November 17, 2006
ROCKVILLE, Md., Nov. 17 -- The FDA said today it has expanded approval of Herceptin (trastuzumab) to include its use as adjuvant therapy in the treatment of early stage HER2 positive breast cancer.
FDA Adds Five New Indications and One Precaution to Gleevec
October 20, 2006
ROCKVILLE, Md. -- The FDA has approved five new indications for Gleevec (imatinib mesylate), a tyrosine kinase inhibitor, all rare life-threatening disorders. At the same time the FDA added a precaution to Gleevec's label about congestive heart failure.
Aricept (donepezil) Wins Indication for Severe Alzheimer's
October 13, 2006
ROCKVILLE, Md. -- Aricept (donepezil), a cholinesterase inhibitor on the market for mild to moderate Alzheimer's disease, today became the first of its class to win FDA approval for severe disease.
FDA Gives Avastin First-Line NSCLC Indication
October 12, 2006
ROCKVILLE, Md. -- The FDA has approved the anti-angiogenic agent Avastin (bevacizumab), in combination with Taxol (paclitaxel) and Paraplatin (carboplatin), as first line therapy for non-small-cell lung cancer.
More Sharp Knives Cut and Slash at FDA
October 09, 2006
WINSTON-SALEM, N.C. -- With the echoes of the Institute of Medicine's unrestrained critique of the FDA last month still resounding, two more broadsides calling for major reform were fired today at the beleaguered agency.
FDA Approves Zolinza for Cutaneous T-cell Lymphoma
October 09, 2006
ROCKVILLE, Md. -- The FDA has approved Zolinza (vorinostat) capsules as second-line therapy for cutaneous T-cell lymphoma that is refractory or recurrent.
FDA Approves Antipsychotic Drug for Irritability in Autistic Children
October 09, 2006
ROCKVILLE, Md. -- The FDA has approved Risperdal (risperidone), an adult antipsychotic agent, for symptomatic treatment of irritability in autistic children and adolescents.
Novartis to Add Congestive Heart Failure to Gleevec Precautions
October 03, 2006
FLORHAM PARK, N.J. -- Novartis Oncology said today it would send letters to U.S. physicians this week advising them of a possible link between Gleevec (imitinib mesylate), the tyrosine kinase inhibitor, and congestive heart failure.