Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Acceptance, Achondroplasia Regulatory, BioMarin, Children, FDA, NDA, regulatory, reports, US, Vosoritide / November 4, 2020

Shots: The acceptance marks the first marketing application accepted for achondroplasia in the US with an anticipated PDUFA date as of Aug 20, 2021. The US FDA is not planning to hold an advisory committee meeting to discuss the application Additionally, the company is expecting to complete enrollment in a P-II study assessing vosoritide in …

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