A House investigation released last week unearthed a trove of documents that shed new light on the polarizing approval and disastrous rollout of Aduhelm, the first new drug for Alzheimer’s disease in two decades. But crucial questions remain for the Food and Drug Administration, Biogen, and the future of treating Alzheimer’s disease.
The FDA has not made clear just what it has changed since the Aduhelm debacle, and the revelations about its inner workings — and the blow to its credibility — came just days before the agency is expected to approve another medicine for Alzheimer’s.