FDA Approvals

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.
Tesaro Inc said on Wednesday that the US Food and Drug Administration approved an intravenous version of its drug to treat chemotherapy-induced nausea and vomiting in adults.
The US Food and Drug Administration has approved the second CAR T-cell therapy, indicated for certain types of non-Hodgkin lymphoma.