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.
Regulatory authorities in six countries have granted 10 sales authorizations for Yondelis. Five of those authorizations are for Yondelis (trabectedin) in combination with Caelyx (pegylated liposomal doxorubicin) for treating relapsed platinum-sensitive ovarian cancer, in Bangladesh, Costa Rica, Kuwait, Moldavia and Saudi Arabia The other five authorizations are for Yondelis for soft tissue sarcoma, in Bangladesh,... […]
FDA approved the American College of Radiology’s alternative standard request to allow mammography facilities to use the new Digital Mammography Quality Control Manual and Digital Mammography QC Phantom in routine QC of digital equipment. The new manual and phantom will aid in ensuring uniformity of QC testing, the ACR said. The FDA alternative standard specifies... […]
Veritas Genetics introduced Veritas myGenome, a whole genome sequencing platform for less than $1,000, including interpretation and genetic counseling. The platform includes a digital report and app to interact with results, on-demand additional genetic counseling via video conferencing, and lifestyle-relevant genetic information that can be shared with non-clinical service providers such as fitness coaches and... […]
NanoString Technologies Inc. entered into a collaboration agreement with Merck, through a subsidiary, to develop and commercialize a novel diagnostic assay to predict response to Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy. Under the terms of the collaboration agreement, NanoString will be responsible for seeking regulatory approval for and commercialization of the diagnostic test. NanoString will be... […]
