The FDA has approved an HPV DNA test to be used as a primary screening method for cervical cancer in women 25 and older. The test can also give insight into future risk of cervical cancer.
The FDA today approved obinutuzumab (Gazyva) for the treatment of chronic lymphocytic leukemia, to be used in combination with chlorambucil.
The US Food and Drug Administration approved the multi-kinase inhibitor regorafenib (Stivarga) yesterday, for the treatment of patients with unresectable metastatic gastrointestinal stromal tumors (GIST) that no longer respond to imatinib and sunitinib.
The FDA has approved ado-trastuzumab emtansine (Kadcyla), known as T-DM1 in development, for the treatment of women with metastatic HER2-positive breast cancer.
The FDA has approved pomalidomide (Pomalyst) to treat patients with relapsed or refractory multiple myeloma who have received at least two prior therapies.
The US Food and Drug Administration has approved imatinib (Gleevec) for the treatment of newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) in children.
The expanded FDA approval of abiraterone acetate (Zytiga) now includes its use prior to chemotherapy in men with metastatic castration-resistant prostate cancer.
The US Food and Drug Administration (FDA) has approved cabozantinib (Cometriq) for the treatment of metastatic medullary thyroid cancer, a rare type of thyroid cancer that makes up about 4% of all cases.
The FDA today approved omacetaxine mepesuccinate (Synribo) for the treatment of adults with chronic myeloid leukemia (CML) who are resistant to other therapies.
AVEO Pharmaceuticals Inc has announced that it has submitted a new drug application for tivozanib to the US Food and Drug Administration for the treatment of metastatic renal cell carcinoma.