FDA approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after hematopoietic stem cell transplantation. This is the first FDA-approved therapy for treatment of severe hepatic VOD. Hepatic VOD can occur in patients who receive chemotherapy and HSCT. The efficacy of Defitelio was investigated... […]
FDA published a draft guidance of recommendations for biosimilar product labeling.
FDA approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia.
The University of Pennsylvania and Genisphere LLC formed a collaborative research agreement to study targeted nanotherapeutics. The collaboration between Genisphere, provider of the 3DNA drug delivery platform, and UPenn’s Theresa Busch, will utilize a breast cancer model to study photodynamic therapy. Photosensitizing drugs are administered to patients prior to surgery, and then activated by visible […]
FDA approved a hepatitis C virus quantitative RNA test to be used as an aid in the diagnosis of HCV infection for certain patient populations.
FDA granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery. “Atezolizumab was granted Priority Review designation based... […]
FDA granted an Orphan Drug Designation to VAL-083 for the treatment of medulloblastoma. The investigational drug candidate, developed by DelMar Pharmaceuticals Inc., previously received an orphan designation for glioblastoma in the U.S. and in Europe. VAL-083 is a first-in-class chemotherapeutic. In more than 40 phase I and II clinical studies sponsored by the NCI, VAL-083... […]
FDA is alerting health care professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines.
The China Food and Drug Administration approved the CINtec PLUS Cytology test, developed by Roche, for identifying women with cervical pre-cancer. A multi-center study of five participating hospitals throughout China revealed greater overall performance of combined sensitivity and specificity of the CINtec PLUS Cytology test in determining which women are at higher risk of developing... […]
FDA approved Xalkori (crizotinib) to treat people with metastatic non-small cell lung cancer whose tumors have an ROS-1 gene alteration. Xalkori, sponsored by Pfizer, is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC. FDA previously granted the Xalkori expanded use application breakthrough therapy designation and priority review status.
