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Dec 12, 2025 12:00 PM

FDA Approves Amgen's Drug For Rare Muscle Disorder

The U.S. Food and Drug Administration (FDA) on Thursday approved Amgen Inc.’s (NASDAQ:AMGN) Uplinza (inebilizumab-cdon) for generalized myasthenia gravis (gMG).

The approval covers adult patients who are anti-acetylcholine receptor (AChR) and anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

gMG is a rare, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause fluctuating muscle weakness.

This is the third indication for Uplinza.

The approval offers patients a new targeted ...