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

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 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, ...

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 ...

Review extended: The FDA pushed back its decision on Leqembi IQLIK by three months to August 24, 2026, after requesting more information from Biogen and Eisai. Reason for delay: The agency classified ...

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 ...

The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s Alzheimer’s drug Aduhelm, which was “rife with irregularities ...

Key dosing differences between Eli Lilly’s Kisunla and Biogen’s Leqembi are about to come to a head in the Alzheimer's market ...

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 biotech's growth portfolio continues to add to its overall top line.

Biogen reported better-than-expected first-quarter earnings and revenue on Wednesday, and trimmed its full-year earnings outlook, citing charges related to business development activity.