FDA News & Updates
The US Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. Read More ›
Today the US Food and Drug Administration (FDA) expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Read More ›
The US Food and Drug Administration (FDA) today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. Read More ›
The US Food and Drug Administration (FDA) today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS)—liposarcoma and leiomyosarcoma—that cannot be removed by surgery (unresectable) or is advanced (metastatic). Read More ›
The US Food and Drug Administration (FDA) granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non–small-cell lung cancer (NSCLC) whose disease has progressed after other treatments, and with tumors that express a protein called PD-L1. Read More ›
On September 30, 2015, the US Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma. Read More ›
- Dinutuximab FDA-Approved for Pediatric Patients with High-Risk Neuroblastoma
- First HDAC Inhibitor, Panobinostat, Approved for Patients with Multiple Myeloma
- Palbociclib Approved for Metastatic Breast Cancer in Postmenopausal Women
- FDA Expedites Approval of Lenvatinib for Refractory Differentiated Thyroid Cancer
- Nivolumab First Immunotherapy to Get FDA Approval for Metastatic Lung Cancer
- Lenalidomide Combined with Dexamethasone Receives Expanded Indication for Patients with Newly Diagnosed Myeloma
Bevacizumab (Avastin; Genentech) received FDA approval on January 23, 2013, for use in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy for treating patients with metastatic colorectal cancer (mCRC) with disease that has progressed on a regimen containing first-line bevacizumab. Read More ›
The US Food and Drug Administration (FDA) approved doxorubicin hydrochloride liposome injection (Sun Pharma Global FZE) for the treatment of patients with ovarian cancer with disease progression after platinum-based chemotherapy and for the treatment of AIDS-related sarcoma in patients after failure of systemic chemotherapy or intolerance to that therapy. Approval for doxorubicin hydrochloride liposome injection was granted on February 4, 2013. Read More ›