Biotech leaders say uncertainty at FDA threatens drug development

Biotech Leaders Concerned About FDA Uncertainty

Biotech leaders are expressing concern that uncertainty at the FDA is threatening drug development.

The recent rejections of Replimune and Capricor therapies by the FDA have highlighted the issue of instability at the agency.

“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.”

CEOs of Replimune Group and Capricor Therapeutics discussed the importance of a stable FDA at the STAT Summit.

The Trump administration's impact on the FDA has raised concerns among biotech companies.

Author's Summary

FDA uncertainty threatens biotech innovation.

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STAT STAT — 2025-10-16