Harmony Biosciences (HRMY) announced results from its bioequivalence study evaluating pitolisant gastro-resistant formulation. With findings from both the pivotal BE and dosing optimization studies, ...

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., June 24, 2024 /PRNewswire/ -- Harmony Biosciences (HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application ...

PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration ...

Prescription Drug User Fee Act date is June 21, 2024 About NarcolepsyNarcolepsy is a rare, chronic, debilitating neurological disease of sleep-wake state instability that impacts approximately 170,000 ...

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 ...

PLYMOUTH MEETING, Pa., Oct. 13, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients ...

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 ...

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) ...