Ascendis Pharma A/S announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in response to the FDA?s ongoing review of the New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months, to August 14, 2024, to provide time for a full review of the submission.
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- Ascendis Pharma A/S Announces Extension of U.S. Food and Drug Administration Review Period for TransCon PTH for Adults with Hypoparathyroidism