Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children

Shots:The EMA has received MAA for TransCon CNP (navepegritide) for the treatment of children with achondroplasia; NDA is under the US FDA’s priority review (PDUFA: Nov 30, 2025)MAA is supported by 3 trials assessing TransCon CNP vs PBO & up to 3yrs. of OLE data, incl. ApproaCH trial results in children with achondroplasia,…

ByRidhi RastogiOctober 9, 2025

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Insights+: EMA Marketing Authorization of New Drugs in November 2023

Shots:The EMA approved 3 BLA while 6 New Chemical Entities with 1 recommendation and 1 acceptance in November 2023, leading to treatments for patients and advances in the healthcare industryIn November 2023, the major highlighted drugs were Vyjuvek to Treat Dystrophic Epidermolysis Bullosa (DEB) and Vyvgart with Halozyme’s Enhanze for the treatment of…

BySenior EditorDecember 29, 2023

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Insights+: The US FDA New Drug Approvals in August 2021

The US FDA has approved 6 NDAs and 1 BLAs in 2021, leading to treatments for patients and advances in the health care industryThe Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 68 novel products in 2021Additionally, last year in 2020, the US FDA…

BySenior EditorSeptember 16, 2021

Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children

Insights+: EMA Marketing Authorization of New Drugs in November 2023

Insights+: The US FDA New Drug Approvals in August 2021

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