Bristol Myers Squibb Co. (BMY) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL).
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 8, 2026.
The FDA filing acceptance is based on the Phase 3 SWOG S1826 (CA2098UT) study, evaluating Opdivo in combination with AVD for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV cHL.
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Business News
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.