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FDA Updates

Imfinzi (Durvalumab) a New PD-L1 Inhibitor Approved for the Treatment of Advanced or Metastatic Urothelial Cancer

Kisqali (Ribociclib): Second CDK4/CDK6 Inhibitor Approved for Postmenopausal Women with HR-Positive, HER2-Negative Advanced Breast Cancer

Kymriah (Tisagenlecleucel) for Young Patients with Acute Lymphoblastic Leukemia: First FDA-Approved Gene Therapy

Revlimid (Lenalidomide) First Drug Approved for Post-Transplant Maintenance Therapy in Multiple Myeloma

Tecentriq (Atezolizumab) Receives New Indication for First-Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

Verzenio (Abemaciclib) a New CDK4/CDK6 Inhibitor Approved for HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

Vyxeos (Daunorubicin and Cytarabine) Liposomal Combination First Treatment Approved for Patients with High-Risk Acute Myeloid Leukemia

Yescarta (Axicabtagene Ciloleucel) Second CAR T-Cell Therapy Approved for Patients with Certain Types of Large B-Cell Lymphoma

Zejula (Niraparib) First PARP Inhibitor Approved for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The Value of Pre–FDA Approval Healthcare Economic Information Exchange Between Payers and Drug Manufacturers

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