US FDA declines to approve Y-mAbs’s paediatric cancer drug
Y-mAbs said it is assessing the implications of the Food and Drug Administration's (FDA) Complete Response Letter (CRL) and the company's plans for the drug's development programme
The US health regulator yesterday declined to approve a treatment from Y-mAbs Therapeutics for a rare form of nerve cancer in paediatric patients, dragging the company’s shares down 16 per cent in extended trading.
Y-mAbs said it is assessing the implications of the Food and Drug Administration’s (FDA) Complete Response Letter (CRL) and the company’s plans for the drug’s development programme.
The FDA’s decision follows a unanimous