Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Co. (LLY) and Alkermes, Inc. (ALKS) confirmed that the U.S. Food and Drug Administration has set a new Prescription Drug User Fee Act action date of March 12 for its review of the exenatide once weekly new drug application. The revised action date is the result of the FDA's decision to allow five additional days for its review of pending regulatory applications following the agency's recent five-day weather-related closure.
Exenatide once weekly is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. The NDA for exenatide once weekly was submitted in May 2009 and accepted by the FDA in July 2009.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.