The U.S. Food and Drug Administration (FDA) has granted priority review to Bristol Myers Squibb's supplemental Biologics License Application for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine $(AVD)$ for adult and pediatric patients (12 years and older) with previously untreated Stage III or IV classical Hodgkin Lymphoma. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of April 8, 2026. This regulatory milestone could bring a new first-line treatment option for adolescents and adults newly diagnosed with advanced-stage classical Hodgkin lymphoma.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Bristol-Myers Squibb Company published the original content used to generate this news brief via Business Wire (Ref. ID: 20251210833041) on December 11, 2025, and is solely responsible for the information contained therein.
Comments