On Wednesday, Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for excessive daytime sleepiness ...
(RTTNews) - Harmony Biosciences Holdings, Inc. (HRMY) said Monday that a pivotal bioequivalence (BE) study of its pitolisant gastro-resistant (GR) formulation showed that 17.8 mg of pitolisant GR is ...
PLYMOUTH MEETING, PA — Harmony 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 New ...
An open-label, long-term (up to five years) study of pitolisant in patients with narcolepsy. The manuscript focuses on findings from a one-year analysis that assessed the long-term safety and efficacy ...
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration ...
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant gastro-resistant (GR) formulation. With positive ...
Harmony Biosciences Holdings, Inc. (HRMY) has already been able to receive FDA approval for its drug known as WAKIX [PITOLISANT]. It is for excessive daytime sleepiness [EDS] or cataplexy in adult ...
PITTSBURGH, Oct. 15, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced it has acquired Aculys Pharma, Inc., a clinical stage biopharmaceutical company ...
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