FDA Alerts
FDA Expands Zytiga’s use for Late-Stage Prostate Cancer
The US Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.
FDA approves Cometriq to treat rare type of thyroid cancer
The US Food and Drug Administration today approved Cometriq ( cabozantinib ) to treat medullary thyroid cancer that has spread to other parts of the body (metastasized).
FDA Approves Prostate Cancer Imaging Agent
The US Food and Drug Administration approved the production and use of Choline C 11 Injection, a positron emission tomography (PET) imaging agent used to help detect recurrent prostate cancer.
Synribo for Chronic Myelogenous Leukemia Approved by FDA
The US Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.
FDA approves new treatment for advanced colorectal cancer
The US Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).
FDA Approves Children's Brain Tumor Drug
The US Food and Drug Administration today approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA).
FDA Approves Breast Tissue Ultrasound
The US Food and Drug Administration approved the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.
FDA Issues Alert on Reumofan Plus
The U.S. Food and Drug Administration is warning consumers that Reumofan Plus, marketed as a “natural” dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.
Revlimid and Risk of New Cancers
The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid ( lenalidomide ).
Votrient for Advanced Soft Tissue Sarcoma
The U.S. Food and Drug Administration approved Votrient ( pazopanib ) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy.