FDA Approvals

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.

The US Food and Drug Administration (FDA) has approved a therapy for adults with relapsed or refractory acute myeloid leukemia (AML) with a specific genetic mutation.

The US Food and Drug Administration (FDA) had granted expanded approval of a melanoma drug to include pediatric patients.

The US Food and Drug Administration (FDA) has approved a treatment demonstrated to reduce the risk of disease recurrence in patients with early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

The US Food and Drug Administration (FDA) has granted full approval to a treatment for B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.