EMA and FDA set common principles for AI in medicine development

Guiding principles of good AI practice in drug development

Human medicines European public assessment report (EPAR): Zvogra, denosumab, Date of authorisation: 17/11/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Abiraterone Accord, abiraterone, Date of authorisation: 26/04/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Stoboclo, denosumab, Date of authorisation: 14/02/2025, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Rydapt, midostaurin, Date of authorisation: 18/09/2017, Revision: 14, Status: Authorised

International Coalition of Medicines Regulatory Authorities (ICMRA)

List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment

EMA/HMA annual data forum, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 December 2025, 09:00 (CET) to 9 December 2025, 17:30 (CET)

Human medicines European public assessment report (EPAR): Aranesp, darbepoetin alfa, Date of authorisation: 08/06/2001, Revision: 47, Status: Authorised