An article from
Dive Brief
Pasatru’s approval sets up a market battle in a rare indication where the only available treatment has generated disappointing sales.
Published Aug. 20, 2026
Getty Images
Pasatru’s approval sets up a market battle in a rare indication where the only available treatment has generated disappointing sales.
An article from
Dive Brief
Pasatru’s approval sets up a market battle in a rare indication where the only available treatment has generated disappointing sales.
Published Aug. 20, 2026
Getty Images

After more than 10 years in development, Regeneron secured a landmark approval for its monoclonal antibody garetosmab, now…

A Regeneron drug that treats an ultra-rare disease that causes bone to form where it's not meant to be has won approval.

FDA approved Regeneron's Pasatru (garetosmab) for FOP, a rare disease affecting ~900 patients. Annual list price ranges…

Regeneron Pharmaceuticals secured FDA approval for Pasatru, a novel monthly infusion therapy proven to reduce lesions in FOP…

The FDA approved a novel therapy for reducing the formation of heterotopic ossification lesions and flare-ups for adults with…

The planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a…

Regeneron's Pasatru scores FDA approval in ultrarare bone lesions disorder

Regeneron drug for disease that causes dangerous bone growth earns FDA approval

FDA approves Regeneron’s drug for ultra-rare disease that turns tissue to bone

Regeneron Secures FDA Approval For Ultra-Rare Bone Disorder Drug - Regeneron Pharmaceuticals (NASDAQ:REGN

FDA approves Pasatru to reduce lesions, flare-ups in fibrodysplasia ossificans progressiva

FDA Approves Activin Signaling Inhibitor for Bone Disorder

Pharmalittle: We're reading about a Regeneron rare disease drug, an Ultragenyx gene therapy, and more

FDA approves Ultragenyx gene therapy

Ultragenyx, after FDA speed bump, lands 1st gene therapy nod with green light in glycogen storage disease