FDA Approvals

The US Food and Drug Administration has granted breakthrough therapy designation to an EGFR tyrosine kinase inhibitor for the first-line treatment of EGFR-positive non-small cell lung cancer.
The US Food and Drug Administration has approved a therapy to treat adults with advanced, metastatic breast cancer that has progressed on endocrine therapy.
The US Food and Drug Administration has indicated nivolumab for intravenous use in patients with previously treated liver cancer.
The US Food and Drug Administration expanded the approval of a targeted therapy to treat gastric or gastroesophageal junction cancer.
The US Food and Drug Administration has approved the first ever biosimilar for the treatment of various cancers.

The US Food and Drug Administration (FDA) has made the first gene therapy available, marking their approval of a new approach to the treatment of cancer.

The US Food and Drug Administration (FDA) has granted regular approval to a treatment indicated for maintenance therapy in adult patients with any of three malignancies.

The US Food and Drug Administration (FDA) has approved an injection for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The US Food and Drug Administration (FDA) has approved the first fixed-combination therapy for newly-diagnosed, poor-prognosis types of acute myeloid leukemia (AML).

The US Food and Drug Administration (FDA) has granted accelerated approval to a therapy for previously treated colorectal cancer.