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The U.S. Food and Drug Administration (FDA) has decided that an advisory committee meeting is not needed at this point in the review process of Soleno Therapeutics‘ application seeking approval of its extended-release formulation of diazoxide choline (DCCR) to treat Prader-Willi syndrome (PWS). Soleno announced the regulatory update…
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The U.S. Food and Drug Administration (FDA) will review Soleno Therapeutics’ application seeking approval of its extended-release formulation of diazoxide choline (DCCR) for Prader-Willi syndrome (PWS) in patients, 4 and older, with excessive hunger. The new drug application (NDA), filed in July, was granted priority review, shortening…
Prader-Will syndrome is a rare and complex genetic condition that results in a variety of physical and mental symptoms. Learn more about the disease here.
Prader-Willi is caused by genetic changes in a particular area of chromosome 15. Learn more about what causes the disease here.
Symptoms of Prader-Willi range from physical impairments to cognitive and behavioral issues. Learn more about the symptoms of the disease here.
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