Orphan designation: Navenibart Treatment of hereditary angioedema, 10/11/2024 Positive
Orphan designation: Navenibart Treatment of hereditary angioedema, 10/11/2024 Positive
Orphan designation: Navenibart Treatment of hereditary angioedema, 10/11/2024 Positive
Orphan designation: Genetically modified human adenovirus encoding human PH20 hyaluronidase Treatment of retinoblastoma, 10/11/2024 Positive
QRD Appendix I - Adverse event (PhV) MSs reporting details
Orphan designation: Sodium selenate Treatment of frontotemporal dementia, 10/11/2024 Positive
Network Portfolio Roadmap
Orphan designation: Ivosidenib Treatment of chondrosarcoma, 10/11/2024 Positive
Minutes of the COMP meeting 08-10 October 2024
Draft concept paper on the European Platform for Regulatory Science Research
Draft Regulatory Science Research Needs - 2024 update
Shortage of Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))