The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
The Center for Drug Evaluation of China’s National Medical Products Administration granted Breakthrough Therapy designation to olverembatinib, combination with low-intensity chemotherapy, for the first-line treatment of newly-diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia.
FDA granted Orphan Drug designation to rhenium obisbemeda (186Re) for the treatment of leptomeningeal metastases in patients with lung cancer.
FDA approved Tevimbra (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (≥1).
The University of New England recently signed its first intellectual property license agreement with Satya Diagnostics—a company that recently received $100,000 in MaineHealth Bonfire Funding to help it achieve its goal of improving cancer detection and treatment in communities across the world.
FDA accepted for review the resubmission of the Regeneron Pharmaceuticals, Inc.’s Biologics License Application for Ordspono (odronextamab) in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy. The target action date for the FDA decision is July 30.
FDA accepted Bristol Myers Squibb’s supplemental biologics license application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.Â
FDA cleared the LTZ Therapeutics’s Investigational New Drug application for LTZ-301, a first-in-class myeloid engager immunotherapy intended to treat relapsed or refractory non-Hodgkin lymphoma.
Tempus AI Inc. and Stemline Therapeutics Inc. announced a new collaboration. The two companies will leverage Next—Tempus’ AI-enabled care pathway intelligence platform—to help clinicians determine when an ESR1 test may be appropriate.
DeepHealth and ConcertAI’s TeraRecon announced a strategic collaboration to integrate certain capabilities to advance imaging tools and the radiology workflow.Â
