Product Details for: Isembyld
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
150MG/3ML (50MG/ML)
Single-Dose Vial
351(a)
Isembyld
Rx
Proper Name
apitegromab-mstn
apitegromab-mstn
BLA Number
761463
761463
Applicant
Scholar Rock, Inc.
Scholar Rock, Inc.
Original Approval Date
September 11, 2026
September 11, 2026
Date of First Licensure