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A spokesman for GSK said the “science has moved on” since concerns were raised about links between narcolepsy and its H1N1 vaccine, called Pandemrix, which was developed during the flu pandemic 10 years ago.
Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) approved Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its new drug application (NDA) for .......