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 Grants Priority Review for BMS’s Opdivo® (nivolumab) with Chemoto Treat Urothelial Carcinoma

Dec 5, 2023

Bristol Myers Squibb (BMS) announced that the FDA has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.  The FDA assigned a PDUFA goal date of 5 April 2024.

On 30 October 2023, the European Medicines Agency validated BMS’s type II variation application for Opdivo® for the above condition.