FDA has accepted Bristol-Myers Squibb’s supplemental Biologics License Application and granted Breakthrough Therapy Designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib.
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
