Aduhelm

Given the drama around the last two drugs approved for Alzheimer’s dementia, Aduhelm and Leqembi, we have a right to be skeptical.

I spent 15 years as the FDA’s “biotechnology czar” at a time when many of the biopharmaceutical companies were small startups needing guidance as they negotiated the regulatory maze.

The FDA perspective If you need to get up to speed on the controversy, look here. The approval was based on three studies.

What we know – providing context