Biotech Leaders Warn FDA Uncertainty Threatens Drug Development

BOSTON — Replimune Group and Capricor Therapeutics recently faced unexpected setbacks as their long-anticipated drug approvals from the Food and Drug Administration (FDA) were rejected. This development comes amid significant turmoil within the agency, particularly as the Trump administration assumed power, raising concerns among industry leaders about the future of drug development.

During the STAT Summit, the CEOs of these companies emphasized the critical need for stability and transparency at the FDA. Replimune CEO Sushil Patel articulated a stark warning: “It is going to kill drug development if you don’t have consistency and transparency. It’s really going to make it very difficult for us to bring innovative treatments to patients faster.” The implications of such instability extend beyond individual companies, potentially stifling innovation across the biotech sector and delaying access to new therapies for patients in need.