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April 30, 2024
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...
October 5, 2023
/PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and...
June 12, 2023
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...
January 19, 2022
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.
January 18, 2022
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
December 28, 2021
PRESS RELEASE December 28, 2021 Saniona (OMX: SANION), a clinical-stage biopharmaceutical company focused on rare diseases, today announced the initiation of a Phase 2b clinical trial of Tesomet
December 28, 2021
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
December 28, 2021
Investegate announcements from Saniona AB, Saniona Initiates Phase 2b Clinical Trial of Tesomet for Prader-Willi Syndrome
November 5, 2021
An FDA advisory panel has voted overwhelmingly against a new drug application for intranasal carbetocin, intended to treat symptoms associated with Prader-Willi Syndrome.
November 5, 2021
All but one committee member said phase III evidence for carbetocin nasal spray was insufficient