The coronavirus, which emerged in China in late 2019, may no longer be a pandemic, but five years after governments ordered ...
Afternoon sleepiness may indicate hypersomnia, caused by narcolepsy, sleep apnea, or depression. Remedies include caffeine, ...
LUMRYZâ„¢ generated $50.4 million in sales in the fourth quarter, up 158% year-over-year, taking the full-year total to $169.1 million, in line ...
Avadel has invested in expanding its field sales team to reach more physicians, doubling its field reimbursement team to accelerate the pace of ...
Video content above is prompted by the following: What is the significance of low-sodium oxybate formulations for patients with narcolepsy who have comorbid cardiovascular disease (CVD)? Low-sodium ...
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MyChesCo on MSNHarmony Biosciences Faces Regulatory Setback, Outlines Future Plans for PitolisantHarmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has issued a Refusal to File (RTF) letter for its supplemental ...
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 ...
in adult patients with idiopathic hypersomnia (IH). Harmony’s 2025 net revenue guidance of $820-$860 million remains unchanged. “We are disappointed with this short-term setback, but our long ...
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 ...
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