STAT+: Biotech leaders say uncertainty at FDA threatens drug development

Lizzy Lawrence directs STAT’s coverage of the FDA. She previously reported on medical devices. Reach out to Lizzy on Signal at lizzylaw.53.

BOSTON — Earlier this year, both Replimune Group and Capricor Therapeutics anticipated long-awaited approvals from the FDA for their drug candidates.

However, their applications faced rejection amid a period of instability at the agency coinciding with the Trump administration’s transition. At the STAT Summit on Wednesday, the CEOs of both companies discussed the critical need for a stable FDA.

“Without consistency and transparency, drug development is going to suffer significantly,” said Replimune’s CEO, Sushil Patel. “Bringing innovative treatments to patients more swiftly will be a real challenge.”

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   Lizzy Lawrence leads STAT’s FDA coverage and has a background in medical devices reporting. Connect with Lizzy on Signal at lizzylaw.53.