9 September 2025 - Approval based upon Imreplys significantly improving survival, accelerating recovery of white blood cells and platelets, and reducing rates of infection and sepsis after radiation exposure without the need for supportive care such as blood products.
Partner Therapeutics today announced that the European Commission has granted a marketing authorisation in the European Union for Imreplys (sargramostim, rhu GM-CSF), the same formulation that was approved by the US FDA under the brand name Leukine in 2018.