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CHMP backs approval of caplacizumab
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of caplacizumab (Cablivi) for the...
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CHMP recommends CAR T for ALL, DLBCL
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of tisagenlecleucel (Kymriah®,...
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CHMP recommends CAR T for DLBCL, PMBCL
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the chimeric antigen receptor (...
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CHMP backs expanded approval of tocilizumab
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approved use of tocilizumab (...
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FDA lifts hold on trial of MYC inhibitor
The US Food and Drug Administration (FDA) has lifted the clinical hold on a phase 1b trial of APTO-253. APTO-253 is a small molecule that...
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Doc reports favorable results from trial on hold
STOCKHOLM—Interim trial results suggest the EZH2 inhibitor tazemetostat can produce durable responses in patients with relapsed or refractory...
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CPI-613 receives orphan designation for BL
The US Food and Drug Administration (FDA) has granted orphan drug designation to CPI-613 for the treatment of Burkitt lymphoma (BL). CPI-613 is a...
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Many CCSs not concerned about future health
A survey of more than 15,000 childhood cancer survivors (CCSs) revealed that many were unconcerned about their risk of health problems. Thirty-...
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FDA grants priority review to drug for AML
The US Food and Drug Administration (FDA) has accepted for priority review a new drug application (NDA) for glasdegib, an oral SMO inhibitor....
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Perioperative RBC transfusions linked to VTE
Patients who receive red blood cell (RBC) transfusions before, during, or immediately after surgery may have an increased risk of venous...
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Company stops development of eryaspase in ALL
Erytech Pharma said it plans to stop development of eryaspase for acute lymphoblastic leukemia (ALL). This means withdrawal of the European...
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Voxelotor benefits adolescents with SCD
STOCKHOLM—An ongoing phase 2 study suggests voxelotor (GBT440) can benefit adolescents with sickle cell disease (SCD). In the HOPE-KIDS 1 study,...
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Ibrutinib sNDA receives priority review
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica®)...
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Leading researcher in genetics, hematology dies at 84
George Stamatoyannopoulos, MD, who conducted important research into hemoglobinopathies, passed away this month at the age of 84. Dr...
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Avapritinib produces durable responses in SM
STOCKHOLM—The KIT/PDGFRA inhibitor avapritinib has produced durable responses in patients with systemic mastocytosis (SM). In the phase 1...