FDA approved Tavalisse (fostamatinib disodium hexahydrate tablets) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
FDA has issued a draft guidance, “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination,” to describe for sponsors of certain oncology trials an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in a trial of investigational cancer drug or biological products is considered significant risk, non-significant risk, or exempt from further pre-market review.
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.
