The FDA has approved Vykat XR (diazoxide choline) for the treatment of hyperphagia in adults and pediatric patients 4 years ...

Soleno Therapeutics has won US Food and Drug Administration (FDA) approval for diazoxide choline – which will be branded as ...

Soleno Therapeutics, Inc., a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved ...

The United States Food and Drug Administration (US FDA) has approved VYKAT™ XR, a significant milestone as the first approved treatment for hyperphagia in Prader-Willi syndrome (PWS).

Federal regulators are clearing a first-of-its-kind treatment for symptoms of a rare neurodevelopmental disorder that is ...

US FDA approves Soleno Therapeutics’ Vykat XR to treat hyperphagia in Prader-Willi syndrome: Redwood City, California Saturday, March 29, 2025, 18:00 Hrs [IST] Soleno Therapeuti ...

PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to ...

Shares of the Redwood City-based Soleno Therapeutics climbed 38% — the biggest one-day gain since September 2023 — to their ...

Soleno Therapeutics drug Vykat XR has received the first FDA-approval for Prader-Willi. The regulatory decision announced late Wednesday covers the treatment of the excessive hunger, called ...

Credit: Solano Therapeutics. Vykat XR contains an extended-release formulation of diazoxide choline, the crystalline salt of diazoxide. Vykat XR is expected to be available in April 2025.

1 VYKAT™ XR is the first and only FDA-approved treatment for hyperphagia in individuals with PWS. PWS is a genetic disorder estimated to occur in approximately one in every 15,000 live births.