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FDA grants orphan designation to drug for AML
The US Food and Drug Administration (FDA) has granted orphan drug designation to CG’806 for the treatment of patients with acute myeloid leukemia...
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Drug approved for kids with sickle cell anemia
The US Food and Drug Administration (FDA) has approved a hydroxyurea product (Addmedica’s Siklos) for use in pediatric patients with sickle cell...
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Nilotinib label updated with info on discontinuation
The US Food and Drug Administration (FDA) has approved an update to the product label for nilotinib (Tasigna) that includes information about how...
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FDA expands approved use of bosutinib in CML
The US Food and Drug Administration (FDA) has expanded the approved indication for bosutinib (BOSULIF®). The tyrosine kinase inhibitor (TKI) is...
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FDA issues requirements, recommendations for GBCA use
The US Food and Drug Administration (FDA) has issued new safety-related requirements pertaining to gadolinium-based contrast agents (GBCAs) used...
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FDA lifts clinical hold on fitusiran trials
The US Food and Drug Administration (FDA) has lifted the hold on clinical trials of fitusiran, an RNAi therapeutic being developed to treat...
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NK cell product receives orphan designation
The European Commission has granted orphan designation to a natural killer (NK) cell product for the treatment of multiple myeloma. The product,...
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CHMP recommends generic drug for ET
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing...
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Pembrolizumab sBLA receives priority review
The US Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application (sBLA) for the anti-PD-1...
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CRP drives bone destruction in myeloma, team says
New research suggests that C-reactive protein (CRP) drives multiple myeloma (MM) to destroy bone. Researchers found that CRP accelerated the...
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Providers endorse medical marijuana for kids with cancer
A survey of nearly 300 US medical providers revealed that many were open to helping children with cancer access medical marijuana (MM). However,...
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A+AVD improves modified PFS in advanced HL
ATLANTA—Phase 3 trial results suggest one 4-drug combination may be more effective than another as frontline treatment for advanced Hodgkin...
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EC approves new formulation of pegaspargase
The European Commission (EC) has granted marketing authorization for a lyophilized formulation of pegaspargase (ONCASPAR). The product is...
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Technique may be effective for diagnosing NHL
Preclinical research suggests infrared spectroscopy could be used to diagnose non-Hodgkin lymphoma (NHL). Researchers used mid-infrared...
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Method may improve HSC mobilization, engraftment
New research suggests a 2-drug combination might improve hematopoietic stem cell transplant (HSCT) for donors and recipients. Researchers found...