House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval

The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.

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.

In Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug

The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. Now it recommends that the drug be given only to those with mild symptoms.

A New Alzheimer’s Drug Offers More Questions Than Answers

The approval of Aduhelm to treat Alzheimer’s disease has raised hope among older adults, but many doctors wonder if it is warranted.

New Drug Could Cost the Government as Much as It Spends on NASA

The Alzheimer’s treatment will cost $56,000 per patient, and millions may use it. The result: “crazy numbers” for Medicare.

Many Alzheimer’s Experts Say Use of Aduhelm Should Be Sharply Limited

Even those who supported the F.D.A.’s approval of the controversial new drug said authorizing it for anyone with Alzheimer’s disease was much too broad.

Opinion | The F.D.A. Has Reached a New Low

The F.D.A.'s approval of the Alzheimer's drug aducanumab is inexplicable. 

F.D.A. Still Lacks a Permanent Chief, Despite Pressing, Weighty Problems

With the pandemic easing, the federal agency’s long-term agenda for drug approvals or new issues is languishing without a permanent commissioner.

Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug

The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.