Selected EMA news, July 2026

New medicines recommended for approval

• Nylaspeg (pegfilgrastim) – biosimilar
  Intended to reduce the duration of neutropenia (low levels of a type of white blood cell) and the incidence of febrile neutropenia due to chemotherapy

New information on authorized medicines

• Jaypirca (pirtobrutinib) – new indication – conditional approval
  Treatment of chronic lymphocytic leukemia and mantle cell lymphoma (blood cancers)
• Tecvayli (teclistamab) – new indication – conditional approval
  Treatment of multiple myeloma (a type of blood cancer)

Negative CHMP opinions on new medicines

• Yartemlea (Narsoplimab)
  Intended for treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (a complication following blood stem cell transplantation)

Upcoming EMA events

• 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.