Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co. Ltd., completed its rolling New Drug Application submission to FDA for TAS-102 (trifluridine and tipiracil hydrochloride). TAS-102 is an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer.
FDA approved a supplemental biologics license application for Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia.
FDA granted Fast Track designation to SGX301 (synthetic hypericin) for the first-line treatment of cutaneous T-cell lymphoma.
FDA approved Lynparza (olaparib) capsules as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. FDA also approved a molecular companion diagnostic.
FDA granted accelerated approval for Blincyto (blinatumomab) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
The Centers for Medicare & Medicaid Services issued its final payment decision regarding the Cologuard stool DNA colorectal cancer screening test, and will reimburse it at $502 per test.
FDA granted clearance for IQQA-BodyImaging, developed by EDDA Technology, as the latest addition to the IQQA platform and product suite for imaging-guided cancer treatment.
The Broad Institute, Harvard University, the Massachusetts Institute of Technology and Editas Medicine entered into a worldwide license agreement to grant Editas access to intellectual property related to the the CRISPR-Cas9 system genome editing technology.
FDA approved Cyramza (ramucirumab) in combination with paclitaxel as a treatment for advanced or metastatic stomach or gastroesophageal junction adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
VELOS recently activated its Investigational Drug System at MD Anderson Cancer Center.
