These 3 Words From the FDA Ensure the Biogen Drama Is Far From Over

In the FDA's press release announcing the approval of Aduhelm, the agency stated that the approval was reached under an accelerated approval pathway. This means the agency has determined that the drug is "reasonably likely to predict a clinical benefit to patients," but there another trial is necessary to confirm and verify that. That could be problematic for a drug that didn't exactly win everyone over with its results.