Genentech Inc., a unit of Roche Group (RHHBY.PK), and Biogen Idec (BIIB) said that the FDA issued a complete response on the companies' applications for Rituxan plus fludarabine and cyclophosphamide for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia.
The FDA has not requested any new data to complete its review of these applications.
Genentech and Biogen Idec said they will continue final label discussions with the FDA and are committed to making Rituxan in combination with FC an FDA-approved option for people with CLL.
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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.