EMA’s CHMP signals nods and rejections — multiple drug recommendations in December meeting

Europe’s Committee for Medicinal Products for Human Use (CHMP) issued a slate of recommendations including backing new medicines from Hansoh and Cytokinetics and recommending ImmunityBio’s Anktiva and Cytokinetics’ Myqorzo in other dossiers. The committee’s December actions covered approvals and negative opinions across oncology, rare disease and cardiovascular spaces, and included at least one critical review urging rejection of a submission over safety and efficacy concerns. CHMP outcomes will shape European market access and influence parallel regulatory strategies elsewhere.