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REDWOOD CITY, Calif., April 30, 2024 -- Soleno Therapeutics, Inc. , a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the...
/PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and...
ARD-101 shows strong efficacy signals including reduction of hunger and body fat composition in the treatment of Prader-Willi Syndrome, a rare genetic disease...
The FDA’s Division of Psychiatry concluded that the efficacy data available for the proposed 3.2mg dose of LV-101 were insufficient for approval.
The FDA’s Division of Psychiatry has rejected a new drug application for treating hyperphagia, anxiousness and distress associated with Prader-Willi syndrome, according to a press release.As Healio previously reported, the FDA granted priority review for LV-101 (intranasal carbetocin, Levo Therapeutics) in July 2021. In a complete response letter, the FDA determined the therapy was safe and