FDA Approvals, News & Updates
Last November, osimertinib (Tagrisso), a third-generation EGFR tyrosine kinase inhibitor (TKI) that targets EGFR mutations, including T790M, was approved by the US Food and Drug Administration (FDA) for the treatment of patients with metastaticEGFR T790M mutation–positive non–small-cell lung cancer (NSCLC) whose disease progressed during or after EGFR TKI therapy.
On May 18, 2016, the US Food and Drug Administration (FDA) approved atezolizumab (Tecentriq; Genentech) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
ProAir RespiClick (Albuterol Sulfate): First Breath-Actuated Inhaler Approved for the Treatment or Prevention of Bronchospasm
FDA Approves First Treatment for Rare Disease in Patients Who Receive Stem Cell Transplant from Blood or Bone Marrow
On March 30, 2016, the US Food and Drug Administration (FDA) approved defibrotide sodium (Defitelio; Jazz Pharmaceuticals) for the treatment of children and adult patients with hepatic veno-occlusive disease plus kidney or lung abnormalities after hematopoietic stem-cell transplantation. This is the first drug to be approved by the FDA for patients with severe hepatic veno-occlusive disease.
On March 11, 2016, the US Food and Drug Administration (FDA) approved an expanded indication for crizotinib (Xalkori; Pfizer) for the treatment of patients with metastatic non−small-cell lung cancer (NSCLC) that harbors the ROS-1 genetic mutation. Crizotinib is the first and only FDA-approved treatment for this patient population; the drug blocks ROS-1 protein activity in tumors, with the potential to prevent NSCLC tumors from spreading.
On March 4, 2016, the US Food and Drug Administration (FDA) approved a new type of coagulation factor IX (recombinant), albumin fusion protein (Idelvion; CSL Behring), for use in children and adults with hemophilia B. Used to replace a naturally occurring clotting factor functionally deficient or defective in these patients, this is the first coagulation factor-albumin fusion protein drug to be approved by the FDA.
American Health & Drug Benefits publishes a Payers' Guide to New FDA Approvals annually with the goal of providing payers and other healthcare stakeholders a comprehensive review of pharmaceuticals that were newly approved or that received important new indications by the US Food and Drug Administration (FDA) in the previous year.
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Results 81 - 90 of 171
Results 81 - 90 of 171