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

FDA’s Move to Update GSK’s Leucovorin for Autism Raises Questions on Dose, Supply, and Data

FDA; GSK; leucovorin; Wellcovorin; autism; cerebral folate deficiency; drug relabeling; dose; supply; clinical data

FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy

FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter

Cytokinetics’ Phase III Trials Show Promise in Challenging Cardiomyopathy Treatment Dominated by BMS

Cytokinetics, Phase III trials, cardiomyopathy, Bristol-Myers Squibb (BMS), heart failure treatment, myosin inhibitors, omecamtiv mecarbil, clinical data, heart muscle contraction, cardiovascular disease.