GSK faced an FDA advisory committee rejection over safety and dosage concerns for its multiple myeloma drug Blenrep, complicating its return to the U.S. market. Simultaneously, CareDx’s stock plummeted following a proposed local coverage determination restricting the frequency of post-transplant surveillance testing. Regulatory tightening and demands for more rigorous clinical and analytic validations represent key pressures for diagnostics and oncology-focused companies.