FDA reversals leave investors worrying about the fates of other experimental drugs

Published Fri, Mar 6 2026. The FDA in the past year has denied or discouraged applications of at least eight new drugs, according to RTW Investments. 

The agency initially refused to review Moderna’s flu shot before reversing course. Companies have accused the FDA of reversing previous guidance, leaving investors worried about the prospects for other drugs in the pipeline. 

FDA Commissioner Marty Makary and other leaders have publicly pledged flexibility for drugs treating rare diseases. Investors don’t feel like recent moves reflect that.

FDA reversals leave investors worrying about the fates of other experimental drugs