for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS). Soleno expects VYKAT XR to be available in the U.S. beginning in April 2025.
The US Food and Drug Administration (FDA) has approved Soleno Therapeutics’ (Nasdaq: SLNO) Vykat (diazoxide choline) extended ...
The FDA has approved the first therapy to address hyperphagia for children and adults aged 4 years and older with ...
The Food and Drug Administration (FDA) has approved Vykatâ„¢ XR (diazoxide choline) for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome ...
Federal regulators are clearing a first-of-its-kind treatment for symptoms of a rare neurodevelopmental disorder that is ...
Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi ...
Diazoxide choline is the first drug indicated for hyperphagia in the rare genetic disorder. Prior to approval, people with ...
Soleno Therapeutics has won US Food and Drug Administration (FDA) approval for diazoxide choline – which will be branded as Vykat XR – to treat extreme hunger in patients with Prader-Willi ...
Stacy Ward, CEO of the Prader-Willi Syndrome Association | USA, and Susan Hedstrom, Executive Director of the Foundation for Prader-Willi Research, also acknowledged the approval as a pivotal ...