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 ...

NEW YORK – Syros Pharmaceuticals said on Tuesday that its retinoic acid receptor-alpha agonist tamibarotene, which it was testing in combination with azacitidine in patients newly diagnosed with ...

A 31-year-old woman with stage IV breast cancer learns a test ordered more than a year before her diagnosis detected a TP53 ...

In the deal, Nippon Shinyaku can exclusively sell ATSN-101 in the US and develop and sell it in Japan, while Atsena retains rights to other territories.

NEW YORK – Trace Neuroscience launched on Tuesday, having raised $101 million in a Series A financing round and with a lead therapeutic development program exploring an RNA-based treatment approach ...

A Phase I study of invikafusp alfa presented at SITC provided the rationale to enroll patients with TMB-high, MSI-high, and virus-associated tumors in Phase II.

NEW YORK – Alentis Therapeutics on Tuesday announced that it has raised $181.4 million in a series D financing round, and that it will put the funds toward developing antibody-drug conjugates ...

One investigation discussed during the call involves sales reps in China allegedly changing genetic testing results to secure reimbursement for Tagrisso.