Fox Business

House committee questions Biogen drug approval process

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 ...
WRAL TechWire

Biogen’s expensive Alzheimer’s drug OK process was ‘rife with irregularities,’ congressional probe finds

A congressional investigation found that the US Food and Drug Administration’s “atypical collaboration” to approve a high-priced Alzheimer’s drug from Biogen was “rife with irregularities.” The report ...
Washington Examiner

House Dems fault FDA’s ‘atypical’ review process for Biogen’s Alzheimer’s drug

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 ...
MarketWatch

Biogen, under pressure, tells investors it ‘stands by’ the FDA review process for its Alzheimer’s drug

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, ...
Fox Business

FDA chief calls for investigation into Biogen Alzheimer's drug approval process

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 ...
FiercePharma

Biogen, FDA walk back controversial Aduhelm label after weeks of fierce criticism

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 ...
The Boston Globe

Biogen defends Aduhelm approval process, says ‘misinformation’ is fueling controversy

Biogen on Thursday vigorously defended its actions that led to the approval of its controversial new Alzheimer’s drug and said negative media coverage was misleading patients who might benefit from ...
STAT

Federal watchdog will review the controversial FDA approval of Biogen’s Alzheimer’s drug

The federal watchdog at the Department of Health and Human Services will review the process used by the Food and Drug Administration to approve the Alzheimer’s drug sold by Biogen, which has caused ...
The New York Times

F.D.A. Seeks Investigation of Its Own Alzheimer’s Drug Approval

The agency’s acting head said a review should look into whether any interactions between agency staff and the drug developer, Biogen, broke F.D.A. rules. By Rebecca Robbins The Food and Drug ...
STAT

Medicare starts process that could limit access to Biogen’s new Alzheimer’s drug

WASHINGTON — Federal officials on Monday announced Medicare will start a process that could limit seniors’ access to the controversial new Alzheimer’s drug, Aduhelm — the first signals from the key ...
WCVB Channel 5 Boston

FDA leader calls for investigation of approval process for Biogen's controversial Alzheimer's drug

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 ...