The US Food and Drug Administration’s imminent action on Biogen Pharma and Eisai Co., Ltd.’s Alzheimer’s drug aducanumab is bound to be controversial, regardless of whether the agency approves the biologics license application or issues a complete response letter.
US FDA’s Most Controversial Drug Approval Decisions, From A To Z
With action imminent on Biogen’s Alzheimer’s drug aducanumab, the Pink Sheet looks back at 10 of FDA’s most controversial drug approval decisions, from Addyi to Zohydro.
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Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.
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US FDA Commissioner nominee Martin Makary appears set for an easy confirmation after Senate Democrats declined to press him on past inflammatory statements about the agency.
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Among those now leaving the US FDA’s biologics center is Lola Fashoyin-Aje, who was considered a rising star at the agency when she became director of the Office of Therapeutic Products’ Office of Clinical Evaluation in 2024.
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The buyout excludes reviewers, but not project managers. Experts said product reviews likely would be harmed if review team-specific project managers could take the buyout.
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The buyout excludes reviewers, but not project managers. Experts said product reviews likely would be harmed if review team-specific project managers could take the buyout.
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The $25,000 buyout, in addition to the early retirement program and layoffs, is intended to reduce the size of the HHS workforce.
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The Department of Government Efficiency cancelled leases for FDA office and lab space at numerous sites outside the Washington, DC, area, while many buildings on the agency’s White Oak, MD, campus were included on the General Services Administration’s initial list of “non-core” government properties for disposal.