← FDA Drug Approvals (Drugs@FDA)

ISEMBYLD

BLA · Biologics License Application · Sponsor: SCHOLAR ROCK INC · Approved 2026-09-11

Drug application

FDA Application #

BLA761463

Application type

Biologics License Application

Brand name

ISEMBYLD

Generic name

Apitegromab-Mstn

Active ingredients

APITEGROMAB-MSTN

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

SCHOLAR ROCK INC

First approval

2026-09-11

Source

Authoritative

Drugs@FDA application overview

Machine

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