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0 0 0.00252623396813064 -0.00485814224640497 -0.00485814224640497 0.00419743490089392 -0.000388651379712321 -0.0151574038087835
Stock impact report

U.S. Food and Drug Administration (FDA) Grants Priority Review to Bristol Myers Squibb's Application for Opdivo® (nivolumab) Plus Chemotherapy Combination for Classical Hodgkin Lymphoma [Y...

Bristol-Myers Squibb Company (BMY) 
Last bristol-myers squibb company earnings: 2/6 07:05 am Check Earnings Report
US:NYSE Investor Relations: bms.com/investors.html
Company Research Source: Yahoo! Finance
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's acceptance of our supplemental Biologics License Application for priority review marks a pivotal milestone as we aim to bring a new and much-needed first-line option to adolescents and adults newly diagnosed with advanced-stage classical Hodgkin lymphoma," said Monica Shaw, Senior Vice President, Oncology Commercialization, Bristol Myers Squibb. " Opdivo in combination with AVD represents a potential new standard of care in the frontline treatment of advanced cHL for adolescents and adults. Hodgkin lymphoma remains a challenging disease, w Show less Read more
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