FDA Approvals

The FDA has given full approval to a drug for the treatment of adults with a recurrent type of brain cancer that has progressed following prior therapy.
The US Food and Drug Administration has approved a next-generation sequencing assay that may be used as a companion diagnostic for therapy selection for solid tumors.
The US FDA has granted approval to a biosimilar for trastuzumab (Herceptin) for the treatment of HER2-positive breast cancer and metastatic stomach cancer.
The US FDA has granted approval to the first breakthrough-designated, next generation sequencing-based test that detects mutations in 324 genes in any solid tumor type.
The FDA has approved an adjuvant treatment for adult patients who are at a high risk of renal cell carcinoma returning after nephrectomy.
The US Food and Drug Administration has expanded the indication for a drug to treat previously untreated follicular lymphoma.
The FDA has granted breakthrough therapy designation to a CAR-T drug for the treatment of patients with relapsed or refractory multiple myeloma.
The US Food and Drug Administration has expanded approvals of therapies for anaplastic large cell lymphoma and chronic myeloid leukemia.
The US Food and Drug Administration has approved a new blood cancer therapy for adult patients who are positive for a genetic mutation.
The US Food and Drug Administration has granted accelerated approval to a therapy for adults with mantle cell lymphoma who have received at least one prior treatment.