Biotech Leaders Concerned About FDA Uncertainty
Biotech leaders are expressing concerns that uncertainty at the FDA is threatening drug development.
The recent rejections of Replimune and Capricor therapies by the FDA have highlighted the issue of instability at the agency.
“It is going to kill drug development if you don’t have consistency and transparency,” said Replimune CEO Sushil Patel.
According to Patel, the lack of stability and transparency at the FDA 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 tumult at the agency as the Trump administration took power.
Author's summary: FDA uncertainty threatens biotech innovation.