Feb. 19, 2025, 17 states involved in a complaint against Section 504 of the Rehabilitation Act, which has been stayed, filed ...
Plymouth Meeting’s Harmony Biosciences’ stock fell 10% on Wednesday after the FDA rejected the expansion of its insomnia drug ...
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Despite the regulatory setback, analysts appear optimistic, noting that Harmony’s long-term prospects remain bright given the ...
By some estimates, nearly half of the world's population suffers from a sleep disorder of some kind. Whether it be sleep ...
Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) received a Refusal to File (RTF) letter from the U.S. Food and Drug ...
Harmony Biosciences is facing more of a nightmare than sweet dreams on the road to securing a new use for its excessive ...
Harmony Biosciences Holdings said the Food and Drug Administration has turned away its application seeking expanded approval of its Wakix narcolepsy drug for the treatment of excessive daytime ...
Harmony Biosciences Holdings, Inc. 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 ...
Harmony Biosciences currently markets pitolisant as WAKIX® in the U.S. for the treatment of EDS or cataplexy in adult patients with narcolepsy and for EDS in pediatric patients 6 years of age and ...
AXSM's fourth-quarter 2024 earnings miss estimates while revenues beat the same. Net product sales rise year over year.