Pitolisant Offers Important Risk-Benefit Profile for Patients With Narcolepsy
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Pitolisant, a selective histamine 3 receptor antagonist/inverse agonist developed by Harmony Biosciences, was recently approved under the brand name Wakix for the treatment of excessive daytime sleepiness in adults with narcolepsy. |
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FDA Rejects Duchenne Muscular Dystrophy Drug Golodirsen, Citing Safety Concerns |
The FDA has issued a complete response letter to Sarepta Therapeutics for its new drug application (NDA) for golodirsen, previously known as SRP-4053, to treat Duchenne muscular dystrophy. |
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