Biotech Firms Rethink Trial Strategies Amid FDA Uncertainties

Some U.S. biotech companies are exploring early-stage drug trials outside the U.S. due to concerns about FDA restructuring under the Trump administration. Executives highlight the appeal of international markets for regulatory stability, although the U.S. remains a significant target for late-stage trials due to its lucrative market.

U.S. biotech companies are increasingly considering moving early-stage drug trials to international markets. Concerns are growing about regulatory delays due to FDA restructuring under the Trump administration.

Traditionally seen as the gold standard, the FDA's mass layoffs and leadership changes are prompting a reevaluation of drug development strategies. Smaller biotech firms are contemplating trials in regions like the European Union and Australia to engage with regulators earlier.

Executives emphasize the importance of stable foreign regulatory bodies, despite the U.S. market's significant financial allure. The shifts may reshape innovation and increase costs for the biotech sector.

(With inputs from agencies.)