Selected EMA news, September 2026

New medicines recommended for approval

• Ruxolitinib Zentiva (ruxolitinib) 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).
• Frehemgo (denecimig)
  Prevention of bleeding episodes in patients with hemophilia A (an inherited bleeding disorder).

New information on approved medicines

• Pepaxti (melphalan flufenamide) – extension of indication
  Treatment of multiple myeloma (a type of blood cancer).
• Tecvayli (teclistamab) – change of indication
  Treatment of multiple myeloma (a type of blood cancer).
• Pradaxa (dabigatran etexilate) – new pharmaceutical form
  Prevention and treatment of blood clots.

Withdrawal of applications for extension of indication

• Alhemo (concizumab)
  Withdrawal of application to extend use to children below 12 years with hemophilia A or hemophilia B (inherited bleeding disorders).

Supply shortages

• Human normal immunoglobulins (verteporfin)
  Treatment of a range of diseases where the immune system (the body’s natural defense against infections) does not work properly.

Upcoming EMA events 

• 2026 annual open meeting of the European Network of Paediatric Research at EMA (EnprEMA) — November 5, 2026

This meeting brings together research networks, healthcare professionals, parents, carers, patient representatives, medicine developers, and regulators involved in pediatric clinical trials. To attend, register before 19 October 2026.

• HMA / EMA multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations — November 12 and 13, 2026

This event brings regulators and stakeholders together to share insights and shape future AI and data use in medicines. Online participation can be requested through the registration link. The live broadcast can be followed with no registration.