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Exceptional Use Recommendation for Nuclear Emergency Drug

Summary by Medscape
The EMA has given a positive opinion for the exceptional circumstances authorization of Imreplys (sargramostim) to treat myelosuppression after acute radiation exposure.

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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, Mass., June 20, 2025 /PRNewswire/ -- 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®…

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Medscape broke the news in United States on Friday, June 20, 2025.
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