Selected EMA news, July 2025

New medicines recommended for approval

• Imreplys (sargramostim)
  Treatment of hematopoietic acute radiation syndrome (depletion of blood cells caused by exposure to radiation)
• Vivlipeg (pegfilgrastim) – biosimilar
  Chemotherapy-induced neutropenia (low level of white blood cells)
• Zemcelpro (allogeneic umbilical cord-derived CD34- cells, non-expanded / dorocubicel) – orphan
  Treatment of hematological malignancies (blood cell cancers) requiring stem cell transplantation

New information on approved medicines

• Darzalex (daratumumab) – new indication
  Treatment of multiple myeloma (a cancer of the bone marrow)
• Imbruvica (ibrutinib) – new indication
  Treatment of mantle cell lymphoma (blood cancers) in patients who are eligible for stem cell transplantation
• Sarclisa (isatuximab) – new indication
  Treatment of multiple myeloma (a cancer of the bone marrow)