FDA Approvals

The US Food and Drug Administration on Friday granted approval for expanded use of AstraZeneca Plc's immunotherapy drug, Imfinzi, to treat non-small cell lung cancer whose tumors can't be surgically removed.
The FDA has approved the first treatment for a type of localized prostate cancer, using a novel endpoint to support the approval.
The FDA has approved a hormone-based chemotherapy in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer.
The US Food and Drug Administration has approved the first radioactive drug for the treatment of a type of pancreatic neuroendocrine cancer.
The US Food and Drug Administration has approved the ipsogen JAK2 assay for use in the diagnosis of all myeloproliferative neoplasms.
The FDA has approved an injection in combination with an established oral therapy for the treatment of acute promyelocytic leukemia.
The FDA expanded the approved use of a therapy for metastasized breast cancer with a certain germline genetic mutation.
The FDA has expanded the approval of denosumab for the prevention of skeletal-related events in patients with bone metastasis from multiple myeloma.
The US FDA has granted approval to an adjuvant therapy for HER2-positive breast cancer at high risk of recurrence.
The US Food and Drug Administration approved an adjuvant treatment for patients with completely resected melanoma.