The agency had previously recommended against marketing authorization for the Alzheimer's disease but reconsidered after a review.

The panels assess genes with strong disease links and clinical management guidelines, but the firm offers limited-evidence genes as an add-on option.

This is the first gene therapy for AADC deficiency to receive US regulatory approval and the first that can be administered directly to the brain.

The pharmaceutical distributor has launched InspiroGene, a business unit offering logistics and other support for ...