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FDA places partial hold on Biohaven's epilepsy drug

Published

10 September 2026

Topic

opportunities

Sectors

Biotech

Geography

United States

Source

Read at biopharmadive.com

Verified

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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Topics

Biotechfdaclinical-holdepilepsy-drugbiohavendrug-approval