FDA accepts Ascendis Pharma’s supplemental biologics license application for TransCon hGH for the treatment of adults with growth hormone deficiency

Ascendis Pharma

12 December 2024 - PDUFA goal date is 27 July 2025.

Ascendis Pharma today announced that the US FDA has accepted for review its supplemental biologics license application in adult growth hormone deficiency for TransCon hGH (lonapegsomatropin-tcgd; marketed as Skytrofa for paediatric growth hormone deficiency.

Read Ascendis Pharma press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier