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FDA places partial hold on Biohaven's epilepsy drug
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Biotech
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United States
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Fusion42 · 10 September 2026 · Fusion42 review
The FDA has placed a partial clinical hold on Biohaven's epilepsy drug opakalim shortly after Biohaven sold the rights to the therapy, affecting a study considered important for potential approval.
This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it.
◆ ◆ The Wire takeaway
You face growing regulatory hurdles after FDA holds on a key epilepsy drug trial. Adjust your clinical development strategy to navigate unexpected regulatory pauses now.
◆ Coverage
3 sources · 10 Sep 2026
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Biotechfdaclinical-holdepilepsy-drugbiohavendrug-approval