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FDA Medication Tracker

← All approvals · Brain & mental health · 2026

Isembyld (apitegromab-mstn)

The FDA approved Isembyld (apitegromab-mstn) on September 11, 2026 to treat spinal muscular atrophy in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatment.
Brand name
Isembyld
Generic name
apitegromab-mstn
FDA approval date
September 11, 2026
Approved use (FDA wording)
To treat spinal muscular atrophy in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatment
Category on this site
Brain & mental health

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.