FDA granted accelerated approval to repotrectinib (Augtyro) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.
FDA has initiated the approval of leucovorin calcium tablets, rushing them to market as part of a push from the Trump administration to identify potential treatments for autism spectrum disorder.
