Opinion/decision on a Paediatric investigation plan (PIP): Kerendia, finerenone, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Renal and urinary disorders, PIP number: EMA/PE/0000235999

Workshop on the use of external controls for evidence generation in regulatory decision-making, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 November 2025, 10:00 (CET) to 3 November 2025, 17:30 (CET)

EMA/PE/0000235991

EMA/PE/0000238063

Variations requiring assessment (veterinary medicines)

Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, tofacitinib citrate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: EMA/PE/0000226763

Meeting of the HMA-EMA group focused on AI with industry stakeholders - June 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, 2 June 2026

EMA/PE/0000236669

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

Human medicines European public assessment report (EPAR): Duvyzat, givinostat, Date of authorisation: 06/06/2025, Revision: 2, Status: Authorised