Orphan designation: efineptakin alfa Treatment of acute radiation syndrome, 24/05/2024 Positive

Orphan designation: Adeno-associated virus serotype 9 containing CRISPR/Cas13Y and guide RNA against the human MECP2 gene Treatment of MECP2 duplication syndrome, 24/05/2024 Positive

Human medicines European public assessment report (EPAR): GalliaPharm, Gallium (68Ga) chloride,Germanium (68Ge) chloride, Date of authorisation: 01/08/2024, Status: Authorised

Minutes of the COMP meeting 18-20 June 2024

Human medicines European public assessment report (EPAR): Tremelimumab AstraZeneca, tremelimumab, Date of authorisation: 20/02/2023, Revision: 1, Status: Withdrawn (authorisation)

Human medicines European public assessment report (EPAR): Cimzia, certolizumab pegol, Date of authorisation: 01/10/2009, Revision: 35, Status: Authorised

Privigen

Ninth Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 June 2024, 09:00 (CEST) to 28 June 2024, 13:25 (CEST)

Human medicines European public assessment report (EPAR): Rilutek, riluzole, Date of authorisation: 10/06/1996, Revision: 34, Status: Authorised

Twelfth meeting of the industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, 4 July 2024