Selected EMA news, August 2026

New medicines recommended for approval

Ruxolitinib Viatris (ruxolitinib hemifumarate) – generic
Treatment of myelofibrosis (a blood cancer that affects the bone marrow), polycythaemia vera (a blood disease leading to production of too many red blood cells), and graft-versus-host disease (a condition where transplanted donor cells attack the body)
Cavoley (pegfilgrastim) – biosimilar
Treatment of neutropenia (low levels of neutrophils, a type of white blood cell) after chemotherapy

Jivi (damoctocog alfa pegol) – extension of indication
Treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII)

Tavneos (avacopan)
Treatment of severe, active granulomatosis with polyangiitis or microscopic polyangiitis (inflammatory conditions of the blood vessels)

A joint European Commission / EMA multi-stakeholder workshop on Regulatory Sandboxes on September 21, 2026 between 13:30-17:00 (CEST), will look at how sandboxes work and discuss their implementation under the revised pharmaceutical legislation. The workshop will be broadcast live. No registration needed.
An online workshop on advancing proof-of-concept data in pediatric oncology drug development will be held on September 21, 2026 between 13:00-16:00 (CEST). Registration is open until September 18.
Save-the-date: The HMA / EMA multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations is scheduled for November 12-13. 2026. This hybrid workshop, bringing regulators and stakeholders together to share insights and shape future AI and data use in medicines, will also be broadcast live. Registration details are coming in September/October.

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