FDA Approvals, News & Updates

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.
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.
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.
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.
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.
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).
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.
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.
  • 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
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