STAT+: Biotech leaders say uncertainty at FDA threatens drug development

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53.

BOSTON — Replimune Group and Capricor Therapeutics both seemed on track to receive long-awaited drug approvals from the Food and Drug Administration earlier this year. 

Then, amid tumult at the agency as the Trump administration took power, their applications were rejected. The companies’ CEOs talked about the importance of a stable FDA at the STAT Summit on Wednesday.

“It is going to kill drug development if you don’t have consistency and transparency,” said Replimune CEO Sushil Patel. “It’s really going to make it very difficult for us to bring innovative treatments to patients faster.”