May 10th, 2012
FDA Advisory Panel Recommends Approval for Weight Loss Drug Lorcaserin
Larry Husten, PHD
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
Larry Husten, PHD
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 […]
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