News Related to Hypertrichosis

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Regeneron's Garetosmab Receives FDA Priority Review for Rare Bone Disorder FOP

Mar 02, 2026

The FDA has accepted Regeneron's Biologics License Application for garetosmab to treat fibrodysplasia ossificans progressiva, granting Priority Review with a target action date of August 2026. The application is supported by Phase 3 OPTIMA trial data.

Soleno Therapeutics Updates Prader-Willi Syndrome Launch and European Regulatory Progress

Feb 15, 2026

Soleno Therapeutics provided updates on its VYKAT XR commercial launch for Prader-Willi syndrome, reporting reimbursement progress across nearly 48 Medicaid programs and over 600 prescribers, while European regulatory review continues for approximately 9,500 additional patients.