Biotech Leaders Express Concern Over FDA Uncertainty
Biotech leaders are warning that uncertainty at the FDA is threatening drug development, citing recent rejections of therapies from Replimune and Capricor.
The CEOs of Replimune and Capricor spoke at the STAT Summit, emphasizing the importance of a stable FDA for innovation.
“It is going to kill drug development if you don’t have consistency and transparency,”said Replimune CEO Sushil Patel, adding that instability will make it difficult to bring innovative treatments to patients faster.
- Replimune Group and Capricor Therapeutics had their drug applications rejected by the FDA earlier this year.
- The rejections occurred amid turmoil at the agency during the Trump administration's transition to power.
Author's summary: FDA uncertainty threatens biotech innovation.
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