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Breast Cancer, FDA Updates
Talzenna (Talazoparib) New PARP Inhibitor Approved for the Treatment of HER2-Negative Advanced Breast Cancer with Germline BRCA Mutation
Lisa A. Raedler, PhD, RPh, Medical Writer
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FDA Updates, Lung Cancer
Vizimpro (Dacomitinib) Approved for First-Line Treatment of Metastatic Non–Small-Cell Lung Cancer with EGFR Mutation
Loretta Fala, Medical Writer
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FDA Updates, Leukemia
Xospata (Gilteritinib) First Drug Approved as Monotherapy for Adults with Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation
Lisa A. Raedler, PhD, RPh, Medical Writer
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FDA Updates
Vitrakvi (Larotrectinib) First TRK Inhibitor Approved by the FDA for Solid Tumors Based on a Genetic Mutation
Lisa A. Raedler, PhD, RPh, Medical Writer
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FDA Updates
Udenyca (Pegfilgrastim-cbqv) Second Biosimilar Approved to Reduce the Incidence of Infection Associated with Febrile Neutropenia
Lisa A. Raedler, PhD, RPh, Medical Writer
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FDA Updates, Prostate Cancer
Yonsa (Fine-Particle Abiraterone Acetate) New Formulation Approved for Metastatic Prostate Cancer
Loretta Fala, Medical Writer
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Breast Cancer, FDA Updates
FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer
Yvette Florio Lane
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FDA Updates
Tibsovo Now FDA Approved as First-Line Treatment for AML with IDH1 Mutation
Yvette Florio Lane
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Renal-Cell Carcinoma, FDA Updates
FDA Approves Pembrolizumab plus Axitinib for Advanced Renal-Cell Carcinoma
Yvette Florio Lane
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Lung Cancer, FDA Updates
April 16, 2019 – FDA Approvals, News & Updates
Yvette Florio Lane
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