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Product safetyFDAUnited StatesImports

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ISEMBYLD (apitegromab-mstn)

26 October 2026

In plain English

FDA announces issuance of a priority review voucher to the sponsor of the rare pediatric disease product ISEMBYLD (apitegromab-mstn), now approved.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
26 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ISEMBYLD (apitegromab-mstn), approved
The full text is at the source

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