Tecartus (brexucabtagene autoleucel) received FDA approval for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
The FDA granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.
The European Medicines Agency validated the Marketing Authorization Application of the fixed-dose combination of Opdivo (nivolumab) and relatlimab, a LAG-3-blocking antibody, for first-line treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with advanced, unresectable or metastatic melanoma.
The MD Anderson Cancer Center and Schrödinger, Inc. today announced a two-year strategic research collaboration focused on the development of Schrödinger’s WEE1 inhibitor program, an investigational therapeutic approach designed to target the WEE1 kinase.
NEXT Oncology and Virginia Cancer Specialists have joined forces, launching NEXT Virginia, a cancer clinic, in September 2021.
The FDA granted 510(k) clearance to the Dayspring Lite treatment for lymphedema and venous disease.
The FDA granted Breakthrough Device designation to the Novilase Interstitial Laser System and its proposed indication for use: the focal destruction of malignant breast tumors in adult women seeking a breast conserving procedure.
The FDA granted Fast Track designation to Acelarin (NUC-1031), currently being evaluated in a phase III study, NuTide:121, for the first-line treatment of patients with advanced biliary tract cancer.
The FDA accepted for priority review the supplemental Biologics License Application for PD-1 inhibitor Libtayo (cemiplimab-rwlc), a monoclonal antibody, to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.
The FDA issued a draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.
