The FDA posted 14 new drug rejection letters (CRLs) online, resuming public releases after prior pauses tied to litigation risk and heightened sensitivity around CRL content. The agency’s updated posting cadence underscores continued regulatory scrutiny of chemistry, manufacturing, and controls. Separately, the FDA’s third rejection for an investigational liver cancer combination highlights how manufacturing or facility inspection findings can stall programs even after prior submissions. For sponsors, these actions signal a continued emphasis on operational compliance alongside clinical evidence.