Day One Biopharmaceuticals Announces FDA approved of New Drug Application for relapsed or refractory pediatric low-grade glioma (pLGG)

Yesterday Day One Biopharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved their

New Drug Application (NDA) for relapsed or refractory pediatric low-grade glioma (pLGG), the most common form of childhood brain tumors. FDA approval means that the drug is now available for prescription by health care professionals in the United States.

Jeremy Bender, Ph.D., chief executive officer of Day One shares that, “this approval ushers in a new day for children living with pLGG, and we are pleased that we can deliver the first and only targeted medicine for both BRAF fusions and mutations, for children living with relapsed or refractory pLGG, the most common form of pediatric brain cancer.”

Y find our Community Statement here.