News

PharmExec17h

Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
PharmTech20h

CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...
Applied Clinical Trials Online17h

FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.