News Related to Swissmedic

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Swissmedic Authorizes Three Orphan Drugs for Rare Diseases: Breyanzi, Alhemo, and Ekterly

Jun 22, 2026

Swissmedic has authorized three orphan drugs for rare diseases: Breyanzi for mantle cell lymphoma, Alhemo for haemophilia A and B, and Ekterly for hereditary angioedema. The decisions include a new indication extension for Breyanzi, an expanded indication for Alhemo, and the initial authorization of Ekterly as part of a joint international regulatory initiative.

Enhertu Plus Pertuzumab Approved for First-Line HER2+ Metastatic Breast Cancer

Feb 24, 2026

Enhertu combined with pertuzumab received FDA approval for first-line treatment of HER2-positive metastatic breast cancer, marking the first new treatment in a decade. Real-world data show trastuzumab deruxtecan efficacy is consistent across patient subgroups.