Human medicines European public assessment report (EPAR): Osenvelt, denosumab, Date of authorisation: 14/02/2025, Revision: 3, Status: Authorised

Applications for new human medicines under evaluation: July 2025

Human medicines European public assessment report (EPAR): Fampridine Accord, fampridine, Date of authorisation: 24/09/2020, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Duvyzat, givinostat, Date of authorisation: 06/06/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Aldara, imiquimod, Date of authorisation: 18/09/1998, Revision: 33, Status: Authorised

Regulatory science research needs

Regulatory Science - Research needs - 2025 update

Human medicines European public assessment report (EPAR): Tolura, telmisartan, Date of authorisation: 04/06/2010, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Soliris, eculizumab, Date of authorisation: 20/06/2007, Revision: 40, Status: Authorised

Workshop on the use of Bayesian statistics in clinical development, Online, European Medicines Agency, Amsterdam, the Netherlands, 17 June 2025