FDA granted Breakthrough Therapy designation to PKC412 (midostaurin), an investigational treatment for adults with newly-diagnosed AML who are FLT3 mutation-positive, as detected by an FDA-approved test, and who are eligible to receive standard induction and consolidation chemotherapy. The designation is primarily based upon results from the phase III RATIFY clinical trial. This study was conducted...
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.
