Acalabrutinib Approved for CLL Under New International Collaboration
The FDA granted a supplemental approval to acalabrutinib for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Acalabrutinib...
Bristol-Myers Wins $752 Million From Gilead in Patent Dispute
Bristol-Myers Squibb has won a $752 million lawsuit against Gilead Sciences to settle a U.S. patent dispute regarding the chimeric antigen receptor (CAR) T-cell...
FDA Approves Voxelotor for Sickle Cell Disease
The FDA has approved voxelotor, a once-daily oral therapy that modulates hemoglobin affinity for oxygen by binding to hemoglobin S and stabilizing it, to...
FDA Struggles to Hire Overseas Drug Facility Inspectors
From 2016 to 2018, the FDA’s overseas drug facility inspections decreased by about 10%, in part because the agency has struggled to hire new...
FDA Approves Zanubrutinib for Relapsed/Refractory Mantle Cell Lymphoma
The FDA has granted accelerated approval to zanubrutinib, an inhibitor of Bruton tyrosine kinase (BTK), to treat adults with mantle cell lymphoma who have...
Crizanlizumab-tmca Becomes First Approved Targeted Therapy for Sickle Cell Disease
The FDA approved crizanlizumab-tmca to reduce the frequency of vaso-occlusive crisis in patients aged 16 and older with sickle cell disease (SCD). The agent...
Gene Editing Therapy Shows Early Benefit for Patients With SCD and Beta Thalassemia
CRISPR Therapeutics and Vertex Pharmaceuticals have reported that the first two patients to receive an experimental gene editing treatment for SCD and beta thalassemia...
Luspatercept-aamt Approved to Treat Anemia in Beta Thalassemia
The FDA approved luspatercept-aamt for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
The approval...
FDA Expands Rivaroxaban’s Indication to Include Hospitalized Patients
The U.S. Food and Drug Administration (FDA) approved the direct oral anticoagulant rivaroxaban for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill...
National Academy of Medicine Releases Report on Clinician Burnout
In a newly published report, the National Academy of Medicine called for systematic changes from health care organizations, educational institutions, and all levels of...
Current Issue
January 2020 Annual Meeting Edition
This issue features highlights from the 2019 ASH Annual Meeting, reflections on physician wellness, and more.
