FDA releases draft guidances on biosimilars, medical communicationsJanuary 19, 2017PharmacyRelated Issues
FDA issues CRL for IV formulation of antiemetic agentJanuary 14, 2017Leukemia, Myelodysplasia, TransplantationLymphoma & Plasma Cell DisordersMultiple MyelomaPharmacyRelated Issues
Venetoclax approved to treat CLL in AustraliaJanuary 12, 2017Leukemia, Myelodysplasia, TransplantationLymphoma & Plasma Cell DisordersPharmacyNon-Hodgkin LymphomaAggressive Lymphomas
Combo granted orphan designation for CLLJanuary 10, 2017Leukemia, Myelodysplasia, TransplantationLymphoma & Plasma Cell DisordersPharmacyNon-Hodgkin LymphomaAggressive Lymphomas
Company withdraws MAA for biosimilar pegfilgrastimDecember 29, 2016Leukemia, Myelodysplasia, TransplantationLymphoma & Plasma Cell DisordersMultiple MyelomaPharmacy
Bendamustine approved for new indication in JapanDecember 23, 2016Lymphoma & Plasma Cell DisordersPharmacyNon-Hodgkin Lymphoma
Drug granted fast track designation for PNHDecember 22, 2016AnemiaThrombosisPharmacyBleeding Disorders
JCAR017 gets PRIME access, breakthrough designationDecember 21, 2016Lymphoma & Plasma Cell DisordersPharmacyNon-Hodgkin Lymphoma
CHMP recommends authorization of rituximab biosimilarDecember 18, 2016Leukemia, Myelodysplasia, TransplantationLymphoma & Plasma Cell DisordersPharmacyNon-Hodgkin Lymphoma