FDA approved rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
FDA has finalized two guidances to drive the efficient development of a novel technology that scans a person's DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments. The guidances provide recommendations for designing, developing, and validating tests that use the technology, called next generation sequencing.
Karyopharm Therapeutics Inc. received the FDA Fast Track designation for an oral Selective Inhibitor of Nuclear Export compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.
Nanobiotix and MD Anderson Cancer Center said they will collaborate on preclinical research involving NBTXR3, Nanobiotix's lead product.
European Commission has approved an expanded indication for XGEVA (denosumab) for the prevention of skeletal-related events in adults with advanced malignancies involving bone.
NCI has launched a resource for cancer researchers interested in conducting studies using specimens and clinical data collected from cancer treatment trials in NCI's National Clinical Trials Network and former NCI Cooperative Group Program.
Boehringer Ingelheim and OSE Immunotherapeutics announced a worldwide collaboration and license agreement to jointly develop OSE-172, a SIRP-alpha antagonist targeting myeloid lineage cells.
FDA granted an accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease.
Seattle Genetics Inc. and Astellas Pharma Inc. said FDA has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate, for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors.
Hologic, Inc. said the Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology has received PMA approval from FDA and are now available on the 3Dimensions breast tomosynthesis system.
