Biotech leaders say uncertainty at FDA threatens drug development

Biotech Leaders Express Concern Over FDA Uncertainty

Biotech CEOs are warning that uncertainty at the FDA is threatening drug development, citing recent rejections of therapies from Replimune and Capricor.

The rejections, which occurred amidst changes at the agency under the Trump administration, have raised concerns about the stability of the FDA's approval process.

“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 from Replimune and Capricor discussed the importance of a stable FDA at the STAT Summit, highlighting the need for consistency and transparency in the agency's decision-making process.

Author's summary: FDA uncertainty threatens biotech innovation.

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STAT STAT — 2025-10-16

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