European Medicines Agency CHMP Recommends EU Approval of Partner Therapeutics IMREPLYS® (sargramostim, rhu GM-CSF) to Treat Exposure to Myelosuppressive Doses of Radiation (Haematopoietic Sub-syndrome of Acute Radiation Syndrome)

 

Lexington, MA – June 20, 2025 – Partner Therapeutics, Inc. (PTx) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of PTx’s Marketing Authorisation Application (MAA) for IMREPLYS® (sargramostim, rhu GM-CSF), the same formulation that was approved by the U.S. Food and Drug Administration (FDA) under the brand name LEUKINE® in 2018. IMPREPLYS would be indicated for treatment of patients of all ages acutely exposed to myelosuppressive ...

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