Biogen executives sought to assure investors that the science behind its newly approved Alzheimer’s disease drug is firm despite ongoing questions about whether the drug works, how it was approved, ...

The Food and Drug Administration’s approval process for Biogen’s controversial Alzheimer’s drug was “rife with irregularities,” a report from House Democrats concluded. The FDA’s collaboration with ...

Biogen Inc. BIIB shares are trading higher on Friday as the company is continuing its FDA review process for Leqembi Iqlik ...

A report by two House committees questioned the approval process for an Alzheimer’s drug produced by Biogen. Congressional investigators called the Food and Drug Administration’s process "rife with ...

The acting commissioner of the Food and Drug Administration (FDA), Janet Woodcock, is calling for an investigation into communications between Biogen representatives and doctors within the agency ...

Biogen Inc. said it will continue development of its experimental Alzheimer’s drug after getting promising though not ...

Drugmaker Biogen said Wednesday it will give up its ownership of Aduhelm, the Alzheimer’s treatment drug that sparked intense criticism of the company and the Food and Drug Administration (FDA) after ...

Following weeks of fiery criticism for its wide-labeled approval for Biogen’s Aduhelm for anyone with Alzheimer’s disease, the FDA is now narrowing the recommended window of patients to only those ...

In the face of questions about the approval process, the acting commissioner of the Food and Drug Administration is asking for an independent review of what led to last month's approval of a ...