FDA disrupts Harmony's expansion dreams for excessive sleepiness drug Wakix with refusal letter

The agency responded to Harmony's bid for an idiopathic hypersomnia nod for excessive daytime sleepiness med Wakix with a refusal to file letter after a missed phase 3 study.

Feb 19, 2025 - 19:08
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FDA disrupts Harmony's expansion dreams for excessive sleepiness drug Wakix with refusal letter
The agency responded to Harmony's bid for an idiopathic hypersomnia nod for excessive daytime sleepiness med Wakix with a refusal to file letter after a missed phase 3 study.