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MSC product receives orphan designation
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- HT Staff
The US Food and Drug Administration (FDA) has granted orphan drug designation to CYP-001 for the treatment of acute graft-versus-host disease (...
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UCART19 can bridge to transplant in adults
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- HT Staff
LISBON—Preliminary data from a phase 1 trial suggest UCART19 can serve as a bridge to transplant in adults with relapsed/refractory (R/R) B-cell...
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Deaths in patients on emicizumab
- Author:
- HT Staff
Two hemophilia organizations have notified the public of 5 deaths in adult patients receiving emicizumab (Hemlibra). All 5 deaths—occurring in...
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CHMP supports expanded approval for fosaprepitant
- Author:
- HT Staff
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended changing the terms of marketing...
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Phase 1 results with UCART19 in kids
- Author:
- HT Staff
LISBON—Early results from a phase 1, pediatric trial of UCART19 expand upon results observed in children who received the therapy via a...
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CHMP rejects plitidepsin again
- Author:
- HT Staff
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended refusal of marketing authorization for...
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CHMP recommends approval for generic prasugrel
- Author:
- HT Staff
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to a...
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ICER assesses value of CAR T-cell therapies
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- HT Staff
The Institute for Clinical and Economic Review (ICER) has made policy recommendations intended to ensure affordability and access to chimeric...
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Leukemia research pioneer dies at 92
- Author:
- HT Staff
James F.
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Product approved for hemophilia patients in Japan
- Author:
- HT Staff
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the bispecific factor IXa- and factor X-directed antibody emicizumab (Hemlibra...
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FDA clears software for immunohematology labs
- Author:
- HT Staff
The US Food and Drug Administration (FDA) has granted 510(k) clearance for ORTHO CONNECT V2.0, a software system developed by Ortho Clinical...
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CHMP recommends rejection for betrixaban
- Author:
- HT Staff
Portola Pharmaceuticals, Inc.
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Mortality in patients with PTLD
- Author:
- HT Staff
LISBON—A review of recent studies has revealed a “significant burden” of mortality related to post-transplant lymphoproliferative disorder (PTLD...
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Amgen withdraws application for darbepoetin alfa
- Author:
- HT Staff
Amgen has withdrawn its application to expand the existing marketing authorization for darbepoetin alfa (Aranesp), according to the European...
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FDA approves nilotinib for kids with CML
- Author:
- HT Staff
The US Food and Drug Administration (FDA) has expanded the approved indication for nilotinib (Tasigna®) to include the treatment of children. The...