Pharming anuncia la aceptación por parte de la FDA de los Estados Unidos para la revisión prioritaria de su Solicitud de Nuevo Fármaco para Leniolisib ...Middle East

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Pharming anuncia la aceptación por parte de la FDA de los Estados Unidos para la revisión prioritaria de su Solicitud de Nuevo Fármaco para Leniolisib
source : PR Newswire ( Middle East ) () 17
La FDA asignó una fecha objetivo según la ley PDUFA el 29 de marzo de 2023 para la presentación de la NDA con base en datos de extensión de control aleatorizado y a largo plazo para leniolisib como tratamiento para las APDS, una inmunodeficiencia primaria poco común LEIDEN, Países Bajos,...

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