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FDA扩大Ascendis侏儒症候选药物审查

2025-11-28 23:22

Ascendis製藥(ASND) 0
富國銀行(WFC) 0

The US FDA has extended the review time of an NDA for Ascendis Pharma's (ASND) TransCon CNP (navepegritide), a treatment for children with achondroplasia.
The action date is extended by three months to Feb. 28, 2026.
The reason for the extension is additional information submitted by the company on Nov. 5 connected to a post-marketing requirement was deemed a major amendment to the application.

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