Posted by Michael Wonder on 01 May 2023
US FDA issues complete response letter for TransCon PTH in hypoparathyroidism
1 May 2023 - FDA cited concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product.
Ascendis Pharma today announced that the US FDA has issued a complete response letter for the TransCon PTH (palopegteriparatide) new drug application for the treatment of adults with hypoparathyroidism.
