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(Reuters) -The U.S. Food and Drug Administration on Wednesday approved Soleno Therapeutics' drug to treat a rare genetic disorder, making it the first treatment available for patients who experience ...
Federal regulators are clearing a first-of-its-kind treatment for symptoms of a rare neurodevelopmental disorder that is characterized by insatiable hunger.
The FDA has approved Vykat XR (diazoxide choline) for the treatment of hyperphagia in adults and pediatric patients 4 years ...
Vykat XR is specifically indicated to address hyperphagia, or the abnormally strong sensation of hunger, which often leads to excessive eating. Its approval covers both adult and pediatric patients ...
New treatments for Prader-Willi Syndrome and hemophilia; FDA fast tracks a chlamydia vaccine candidate; over-the-counter test cleared for identifying chlamydia, gonorrhea and trichomoniasis.
for those with the rare genetic disorder Prader-Willi Syndrome (PWS), several companies have come up short in their attempts to develop a more advanced treatment for hyperphagia, an insatiable ...
Soleno Therapeutics' Vykat XR has become the first FDA-approved treatment for Prader-Willi syndrome (PWS), a rare genetic disorder that causes excessive appetite and obesity.
10d
News-Medical.Net on MSNUS FDA approves first treatment for hyperphagia in Prader-Willi syndromeThe 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).
for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). Vykat XR contains an extended-release formulation of diazoxide choline ...
Vykat XR is now the only FDA-approved treatment specifically addressing hyperphagia in Prader-Willi syndrome. The FDA approval of Vykat XR was based on data from the Phase III Study C602-RWP ...
FDA approves first treatment to treat insatiable hunger ... the hallmark symptom of the Prader-Willi syndrome, a genetic disorder caused by full or partial deletions on chromosome 15 that affect ...
The drug, to be called Vykat XR, treats hyperphagia, the hallmark symptom of the Prader-Willi syndrome ... hyperphagia after at least one year of treatment. Justice Faith, a 21-year-old from ...
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