Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
PipCast®
PTE
Trade Marks
Webinars

FDA accepts BMS’ sBLA for Neoadjuvant Opdivo® (nivolumab)

Feb 7, 2024

On 7 February 2024, Bristol Myers Squibb (BMS) announced the FDA’s acceptance of its supplemental Biologics License Application (sBLA) for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).  The FDA has assigned a PDUFA goal date of 8 October 2024.   

On 5 December 2023, BMS announced that the FDA has accepted for priority review its sBLA for Opdivo® in combination with cisplatin-based chemotherapy for the treatment of unresectable or metastatic urothelial carcinoma.