In this Managed Healthcare Executive® KCast, Ian Krop, M.D., Ph.D., oncologist and associate professor of medicine at Dana-Farber Cancer Institute in Boston, and Debra Patt, M.D., Ph.D., MBA, ...

The Plymouth Meeting, Pa., company termed the FDA's refusal to file a short-term setback and said its long-term strategy for pitolisant in idiopathic hypersomnia is on track with its focus on a ...

Harmony Biosciences received an FDA Refusal to File letter for pitolisant in idiopathic hypersomnia but plans a Phase 3 trial in Q4 2025. Q4 net product revenue reached $201M, surpassing estimates ...

Idiopathic Hypersomnia (IH) is a rare and chronic neurological disease that is characterized by excessive daytime sleepiness (EDS) despite sufficient or even long sleep time. EDS in IH cannot be ...

(Nasdaq: HRMY) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for the treatment of excessive daytime sleepiness (EDS) ...

Narcolepsy is diagnosed if you take less than eight minutes to fall asleep and you enter the REM stage of sleep in at least two naps during the MSL test. Hypersomnia is diagnosed if you take less than ...