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 FDA and Biogen agreed to narrow the recommended use for the drugmaker's controversial Alzheimer's disease drug Aduhelm. (Biogen) () Following weeks of fiery criticism for its wide-labeled approval ...

This delay is attributed to procedural issues at the European Medicines Agency that have implications for the review process of lecanemab. Lecanemab has been under EMA review since January 2023 for ...

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 ...

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 ...

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 ...

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 ...