Biotech leaders say uncertainty at FDA threatens drug development

Biotech Leaders Express Concern Over FDA Uncertainty

Biotech leaders are warning that uncertainty at the FDA is threatening drug development, following the rejections of Replimune and Capricor therapies.

The CEOs of Replimune Group and Capricor Therapeutics discussed the importance of a stable FDA at the STAT Summit, citing the agency's recent rejections of their applications.

“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.”

The rejections came amid tumult at the agency as the Trump administration took power, highlighting the need for stability and transparency in the FDA's decision-making process.

Autor summary: FDA uncertainty threatens biotech innovation.

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STAT STAT — 2025-10-16

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