5 FDA approval decisions to watch in the second quarter

5 FDA approval decisions to watch in the second quarter

Source: 
BioPharma Dive
snippet: 

The Food and Drug Administration doesn't yet have a new full-time commissioner. But whoever fills the seat in the coming months — be it acting chief Janet Woodcock or another candidate — could start the job with some tough decisions to make.

At the top of the list is whether the agency should clear an experimental Alzheimer's drug from Biogen. That decision is among the most consequential the FDA has ever faced, as an approval or rejection will have ripple effects on Alzheimer's research, the agency's reputation and the biotech sector for years to come.