US FDA proposes higher bar for accelerated approvals for cancer drugs
(Reuters) -The U.S. health regulator on Friday proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates. The Food and Drug Administration’s proposed recommendation follows criticism for the accelerated approval pathway, as well as an independent federal review into it after the controversial nod for Biogen Inc’s Alzheimer’s treatment Aduhelm. Accelerated approvals allow the agency to move therapies that target serious and […]