31 results

• 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.

• 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.

• Public Citizen Calls For Investigation Into Collaboration Between FDA and Biogen Over New Alzheimer’s Drug

  December 15, 2020

  Irvin Jackson

  Public Citizen is calling for an investigation into the relationship between the FDA and Biogen after the agency helped shepherd an experimental Alzheimer's disease drug through its approval process despite clinical trials being cancelled due to its ineffectiveness.

• Tysabri PML Risk-Minimization Strategies Working, Study Finds

  September 16, 2019

  Martha Garcia

  Tysabri PML rates are on the decline after preventative guidelines went into effect, according to a new study.

• Zinbryta Brain Inflammation Risks Outweigh Benefits: EMA

  May 22, 2018

  Irvin Jackson

  European regulators say they have positively confirmed that the recently recalled MS drug Zinbryta had health risks that outweighed any potential benefits, indicating that causes of severe brain inflammation were impossible to predict.

• Zinbryta Risks Prevented Use As MS Drug, Despite Effectiveness of Treatment: Report

  April 25, 2018

  Irvin Jackson

  A new study indicates that Zinbryta side effects were so severe it could have never become a major drug product, raising questions as to why it was approved when there were less dangerous alternatives.