The FDA today approved its first “breakthrough” medicine—Genentech’s Gazyva™ (obinutuzumab or GA101), in combination with chlorambucil chemotherapy for people with previously untreated chronic lymphocytic leukemia (CLL). The Roche subsidiary trumpeted the approval as FDA’s fifth for a new drug developed by the company in the past three years. Gazyva is the first approved drug to have been designated a Breakthrough Therapy by the FDA.
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