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.
The White House Office of Management and Budget has published a “Regulation for Federal Financial Assistance,” a proposed rule that seeks to fundamentally redraw the ground rules for all federally funded research. On the other side are America’s scientists who aren’t just crying foul—they are readying for a political fight.
