FDA accepted a supplemental New Drug Application for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia. The sNDA was granted priority review.
A federal judge ruled that the FDA lacks the statutory authority to regulate laboratory developed tests, finding squarely in favor of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting the plaintiffs.
