Biotech and Pharma Puzzled as Headless FDA Changes Course on Drug Reviews

The FDA has made several recent surprising moves when it comes to drug reviews, leaving many biotech companies puzzled and frustrated. Acadia Pharmaceuticals expected approval for its anti-psychosis prescription drug Nuplazid, but instead received a critical letter from the FDA regarding its numerous deficiencies. The FDA has also decided to hold an advisory panel to discuss FibroGen’s roxadustat prescription drug, rather than approve it. Six former FDA commissioners have written a letter asking President Biden to fill the empty spot.

“Seemingly overnight, the Food and Drug Administration appears to be taking a more risk-averse stance on drug reviews, leaving drug makers confused and their stock prices battered.” Read more here.

(Source: Adam Feuerstein, 3/9/21)