Did the FDA approve Regeneron’s Pasatru for FOP in adults?

Yes. On August 19, 2026, the FDA approved Regeneron’s Pasatru (garetosmab-grts) for adults with fibrodysplasia ossificans progressiva to reduce new heterotopic ossification and clinician-assessed flare-ups. It became the second approved FOP drug, supported by a 63-patient placebo-controlled study.