The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) delivered a mixed slate of opinions: recommending two drugs already approved in the U.S. while issuing a negative opinion on belumosudil years after FDA approval. In a separate Sanofi‑focused decision CHMP recommended rilzabrutinib (Wayrilz) but rejected Rezurock (belumosudil) as a treatment for chronic graft‑versus‑host disease, citing insufficient benefit in a truncated trial. These divergent outcomes highlight ongoing global regulatory divergence and the CHMP’s rigorous evidence bar, creating uncertainty for cross‑border commercialization strategies and reinforcing the need for sponsors to tailor submissions to European evidentiary expectations.