FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

FDA

10 September 2025 - Today, the FDA approved selumetinib (Koselugo, AstraZeneca Pharmaceuticals) granules and capsules for paediatric patients 1 year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. 

The FDA previously approved selumetinib capsules for paediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

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Michael Wonder

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Michael Wonder