Posts Tagged ‘advisory committee’

May 10th, 2012

FDA Advisory Panel Recommends Approval for Weight Loss Drug Lorcaserin

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of lorcaserin (Lorqess, Arena). The vote was 18 in favor of approval, 4 against, and 1 abstention.

October 19th, 2010

FDA Advisors Recommend No Changes for Aranesp

The FDA Cardiovascular and Renal Advisory Committee has endorsed the status quo for Aranesp (darbepoetin alfa). The committee met on Monday to discuss the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) and voted 15-1-1 against withdrawal of the indication for chronic kidney disease (CKD) patients not on dialysis. The committee also voted against adoption […]