FDA News

The FDA has granted a breakthrough therapy designation to atezolizumab (Tecentriq) for use in combination with bevacizumab (Avastin) as a first-line treatment for patients with advanced or metastatic hepatocellular carcinoma (HCC).

The FDA announced today that it has approved the first biosimilar for the treatment of multiple types of cancer.

The FDA has approved a new agent for the treatment of severe hepatic veno-occlusive disease, a rare but often fatal complication in patients who receive chemotherapy and hematopoietic stem cell transplantation.

The FDA has granted an accelerated approval for Tagrisso (osimertinib) to treat patients with advanced non–small cell lung cancer (NSCLC) positive the EGFR T790M mutation and whose disease worsened following a prior EGFR TKI.