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In the Literature

The FDA has confirmed another strong year regarding the approval of innovative new drugs and biosimilars, including several agents used in the treatment of patients with cancer. Read More ›

On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology drugs that may be effective in the treatment of pediatric cancers. Read More ›

On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA granted Orphan Drug Designation to the agent for the treatment of soft tissue sarcomas. Read More ›

  • Calquence Receives FDA Approval for the Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
  • Despite Some Positive Trends, Report Confirms Lung Cancer Remains the Deadliest Form of Cancer
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On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease. Read More ›

  • Teva Will Resume Production of Vincristine in Response to Shortage
  • FDA Fast-Tracks Opdivo plus Yervoy Regimen for Treatment of Advanced Liver Cancer
  • FDA Grants Accelerated Approval to Brukinsa for Patients with Mantle-Cell Lymphoma
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  • FDA Approves Ziextenzo, Third Biosimilar to Pegfilgrastim for Febrile Neutropenia
  • Trump Will Nominate Dr Hahn as Next FDA Commissioner
  • Researchers Report High Rates of E-Cigarette Use Among Children and Teens
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  • Xospata Extends Overall Survival in Patients with FLT3 Mutation–Positive Relapsed or Refractory Acute Myeloid Leukemia
  • Published Results from KEYNOTE-048 Trial Show Extended Survival with Keytruda Advanced Head and Neck Cancers
  • Discussing Costs of Genomic Testing with Patients
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  • Zejula Now Approved for Late-Line Ovarian Cancer
  • Trump Set to Nominate Hahn as FDA Commissioner
  • FDA Aims to Improve Breast Implant Guidance
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The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study of racial disparities in multiple myeloma, and new drug on the horizon for HER2 metastatic breast cancer. Read More ›

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