FDA accepted the New Drug Application for capivasertib in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen.
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.
