Biotech Leaders Concerned About FDA Uncertainty
Biotech leaders are expressing concerns that uncertainty at the FDA is threatening drug development.
Replimune Group and Capricor Therapeutics, two biotech companies, had their therapies rejected by the FDA earlier this year, despite initially being on track for approval.
“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 CEOs of these companies 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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