Posted by Michael Wonder on 15 May 2024
Ascendis Pharma announces extension of US FDA review period for TransCon PTH for adults with hypoparathyroidism
14 May 2024 - PDUFA goal date extended by three months for further review of submission to 14 August 2024.
Ascendis Pharma today announced that the US FDA notified the Company that information submitted in response to the FDA’s on-going review of the new drug application for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism constituted a major amendment to the new drug application.
