FDA New Drug and Biologic Approvals, 2018 Midyear Review

Hematology/Oncology

• Anticoagulation Reversal: AndexXa (coagulation factor Xa, recombinant, inactivated-zhzo)

• Gastroenteropancreatic Neuroendocrine Tumors: Lutathera (lutetium Lu 177-dota-tate)

• Phenylketonuria: Palynziq (pegvaliase)

• Prostate Cancer: Erleada (apalutamide)

• Thrombocytopenia in Chronic Immune Thrombocytopenia: Tavalisse (fostamatinib)

• Thrombocytopenia in Chronic Liver Disease: Doptelet (avatrombopag)

• Unresectable or Metastatic Melanoma: Mektovi (binimetinib)

• Unresectable or Metastatic Melanoma: Braftovi (encorafenib)

• New Indications/Other Oncology Updates

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Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.

Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.