The Priority Review

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Scholar Rock

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  1. Regulation

    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.