The FDA has started its review of uniQure's gene therapy for neurodegenerative disorder Huntington's, but will require an advisory committee meeting.

Takeda's rusfertide received FDA priority review on Apr 3, 2026; the designation sets a six-month target versus the standard 10 months, accelerating regulatory timing for PV treatment options.

The FDA has started a priority review of Otsuka's triple-acting drug for ADHD, setting up a decision on the first-in-class drug in July.

BeOne nears a possible FDA okay for sonrotoclax in mantle cell lymphoma, hoping to be the second BCL-2 inhibitor in the US after AbbVie's Venclexta.

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The FDA accepted Priority Review of the BLA for Orca-T in several hematological malignancies, including acute lymphoblastic leukemia (ALL).

FDA Priority Review of asundexian marks a key regulatory milestone for factor XIa inhibition in secondary stroke prevention following positive phase 3 OCEANIC-STROKE results.

NeurologyLive is your direct connection to the latest neurology news and interviews with expert neurologists in multimedia formats.

The FDA granted priority review to a supplemental biologics license application for lisocabtagene maraleucel in relapsed/refractory marginal zone lymphoma.

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