FDA Alerts
FDA Approves Zykadia for Late-Stage Lung Cancer
The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
FDA Approves New Rx for Stomach Cancer
The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.
FDA Approves Nexavar to Treat Type of Thyroid Cancer
The U.S. Food and Drug Administration today expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer.
FDA Approves Perjeta for Neoadjuvant Breast Cancer Treatment
The US Food and Drug Administration today granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting).
FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers
The US Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.
FDA Approves Pancreatic Cancer Treatment
The US Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
FDA Approves New Treatment for a Type of Late-Stage Lung Cancer
The US Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.
FDA Approves new Silicone Gel-filled Breast Implant
The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
FDA Approves Xgeva
The US Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer
The US Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.