The FDA resumed posting complete response letters (CRLs) after a reported pause, posting 14 new rejection letters in a single batch. The agency cited “commitment to transparency,” according to the report, signaling a return to more frequent public-facing regulatory messaging for applications under review. The batch included at least one notable oncology package—a camrelizumab plus rivoceranib combination from Hengrui and Elevar—while other companies also received CRLs. Separate coverage notes that FDA posted CRLs online as part of this renewed activity after internal changes and external pressure about how CRL releases were handled. From a biotech operating standpoint, the shift means developers should expect tighter cycles for notification and re-engagement after CRLs, especially when manufacturing, labeling, or clinical data packages need remediation. Companies that were awaiting status may now need to adjust regulatory timelines and resource planning accordingly.
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