Ascendis Pharma (ASND) announced that the FDA notified the Company that information submitted on November 5 related to the post-marketing requirement, in response to the FDA’s ongoing review of the New Drug Application, or NDA, for TransCon CNP for children with achondroplasia, constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months to February 28, 2026.
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