Bayer HealthCare and Onyx Pharmaceuticals have announced FDA priority review designation for Nexavar (sorafenib) supplemental new drug application for the treatment of radioactive iodine-refractory differentiated thyroid cancer. Nexavar ...
Tags: New Drug Application, FDA
The European Commission has granted additional indication for GlaxoSmithKline’s (GSK) Tyverb (lapatinib) in combination with trastuzumab for adult patients with overexpress HER2 (ErbB2), with hormone receptor-negative (HR-) metastatic ...
Tags: European Commission
Castle Biosciences has announced that data from studies of its DecisionDx-Melanoma test confirm previous studies, indicating that the gene expression profile test is a strong predictor for classifying which Stage I or II non-metastatic ...
Specialty pharmaceutical company Sagent Pharmaceuticals has introduced an antineoplastic agent, Docetaxel Injection Concentrate, in three preservative-free vial presentations. Designed to help reduce medication errors, the product ...
Tags: Sagent, Medicine errors
GlaxoSmithKline (GSK) has announced Health Canada approval of a BRAF-inhibitor, Tafinlar, and a first in class MEK-inhibitor, Mekinist, for melanoma patients with BRAF V600 mutation. Both, Tafinlar (dabrafenib mesylate) and Mekinist ...
Tags: Melanoma Drugs, Medicine
Oncology-focused drug development company Curis has obtained the conditional approval for Erivedge (vismodegib) to treat adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery ...
The US Food and Drug Administration (FDA) has cleared Boehringer Ingelheim's tyrosine kinase inhibitor Gilotrif (afatinib) as a new medication for patients with late stage (metastatic) non-small cell lung cancer (NSCLC). The approval also ...
Tags: FDA, Lung Cancer Therapy, Medicine
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's Tafinlar (dabrafenib) and Mekinist (trametinib) as single-agent therapies for unresectable or metastatic melanoma with BRAF V600E mutation. Tafinlar is not indicated ...
Speciality pharmaceutical and diagnostic company, Prometheus is set to begin Proclivity02, a study that compares the sequence of Proleukin (High Dose Interleukin-2 (HD IL-2) therapy at multi centers in US for metastatic melanoma (mM). ...
Astellas Pharma and Medivation have announced the Health Canada approval of Xtandi (enzalutamide) capsules to treat metastatic castration-resistant prostate cancer. The oral, once-daily androgen receptor inhibitor is indicated for ...
Tags: Astellas Pharma, Medicine
Inostics, a molecular diagnostics firm providing blood-based mutation testing, has received the Clinical Laboratory Improvement Amendments (CLIA) license for its clinical laboratory in Baltimore. The receipt of the license would mark a ...
Tags: Clia Certification, Medicine
Celgene International has obtained FDA priority review status for Abraxane (paclitaxel protein-bound particles for injectable suspension) supplemental new drug application (sNDA). The application covers the use of Abraxane and gemcitabine ...
Tags: Celgene sNDA, FDA Priority
The US FDA has approved Algeta's Xofigo (radium-223 dichloride) injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is the first ...
Roche Group member Genentech and Astellas Pharma US announced that the US Food and Drug Administration (FDA) has cleared Tarceva (erlotinib). The tablets are used for the initial treatment of people with metastatic non-small cell lung ...
Tags: FDA, Tarceva Tablets, Astellas Pharma
The US FDA has approved Xofigo (radium Ra 223 dichloride) for the treatment of symptomatic late-stage (metastatic) castration-resistant prostate cancer spread to bones but not to other organs in men. The therapy is indicated for men whose ...