9 results

• Study By Former FDA Advisors Finds Agency Is Biased Towards Approving New Drugs

  August 7, 2023

  Martha Garcia

  A new study warns that the FDA appears to have a bias toward approving new drugs, even when scientific advisors recommend against such approvals.

• Alzheimer’s Disease Drugs Aduhelm, Leqembi May Cause Brain Shrinkage: Study

  April 19, 2023

  Martha Garcia

  A new study warns that Aduhelm and Leqembi, new Alzheimer's disease drugs, may cause brain shrinkage which accelerates the condition instead of treating it.

• Congressional Report Finds FDA Ignored Agency Protocols in Approving Biogen’s Aduhelm Alzheimer’s Drug

  December 30, 2022

  Irvin Jackson

  A House report raises questions about the overly-close relationship between the FDA and Biogen, which led to approval of the Alzheimer's disease drug Aduhelm, despite significant evidence the drug did not work.

• FDA System For Approving New Drugs Found Lacking By Study

  September 24, 2021

  Irvin Jackson

  A new study warns that the FDA fails to rely on previous experience in dealing with the approval of drugs with questionable effectiveness, which could erode public trust.

• Lawmakers Demand FDA Documents on Aduhelm Approval

  September 3, 2021

  Irvin Jackson

  Two powerful House committee chairs are calling on the FDA to provide a raft of information on how and why it approved the controversial new Alzheimer's drug Aduhelm.

• Distrust of FDA Drug Approval Process Leads To Hesitation Prescribing New Meds: Survey

  August 4, 2021

  Russell Maas

  Doctors say they are losing confidence in new drugs approved by the FDA following a number of recent decisions and perceptions of an overly close relationship with the pharmaceutical industry.

• Investigation Into Alzheimer’s Drug Approval Process Requested By Multiple Entities, Including FDA

  July 12, 2021

  Irvin Jackson

  The FDA's Acting Commissioner has asked the Office of the Inspector General to investigate the agency's controversial decision to approve the new Alzheimer's disease drug, Aduhelm, following a wave of criticism and controversy.

• Two FDA Advisory Committee Members Quit Over Controversial Approval of New Alzheimer’s Drug

  June 11, 2021

  Russell Maas

  Two members of an FDA advisory committee have resigned in protest over the approval of a new Alzheimer's disease drug, which many critics say shows no evidence of actually being effective.

• Consumer Group Calls FDA Approval of New Alzheimer’s Drug “Reckless”

  June 8, 2021

  Irvin Jackson

  The FDA faces criticism for the rushed approval of a new Alzheimer's disease drug, which its own advisors say has not been shown to be effective.