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Y-mAbs Gives Thanks For First Approved Drug Danyelza

Gets FDA OK For Neuroblastoma

 
• By Kevin Grogan

US regulators refused to accept the file for one of Y-mAbs's neuroblasoma drugs – omburtamab – in October but have given the green light to a second one, naxitamab.

FDA approved background, 3D rendering, blue street sign
Y-mAbs have got its first US approval • Source: Shutterstock

As Thanksgiving celebrations began, the US Food and Drug Administration gave Y-mAbs Therapeutics Inc. something extra to celebrate by approving Danyelza for neuroblastoma.

The agency gave the green light to Danyelza (naxitamab) late on 25 November for use in combination with granulocyte-macrophage colony-stimulating...

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