FDA issues priority review voucher for ISEMBYLD (apitegromab-mstn)
The FDA announced the issuance of a priority review voucher to the sponsor of ISEMBYLD (apitegromab-mstn), approved September 11, 2026. The voucher is awarded because the product meets the criteria for rare pediatric disease applications under the FD&C Act.
Primary source
Federal Register notice, October 26, 2026
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ISEMBYLD (apitegromab-mstn)
Read the source: Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ISEMBYLD (apitegromab-mstn) federalregister.gov
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