CHMP Rejects Sanofi’s Rezurock Over Clinical Data Issues, Recommends Approval of BTK Inhibitor Wayrilz

Sanofi; CHMP; EMA; Rezurock; Wayrilz; Belumosudil; Rilzabrutinib; chronic graft-versus-host disease; cGVHD; immune thrombocytopenia; ITP; regulatory approval; clinical data

Novartis antibody ianalumab clinches another Phase 3 win in rare blood disease (ITP)

Novartis; ianalumab; VAY736; primary immune thrombocytopenia; ITP; rare disease; Phase 3; time to treatment failure; safe platelet levels; eltrombopag; autoimmune; B-cell depletion; BAFF-R inhibition; Sjögren’s disease; regulatory submissions