Idarucizumab receives full FDA approval

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Dabigatran (Pradaxa)
Photo courtesy of
Boehringer Ingelheim
The US Food and Drug Administration (FDA) has granted full approval to idarucizumab (Praxbind®), the specific reversal agent for dabigatran etexilate mesylate (Pradaxa®). Idarucizumab received accelerated approval from the FDA in October 2015. Now, the drug has full approval for use in reversing dabigatran’s anticoagulant effects in... [Read Article]
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Fostamatinib approved to treat adults with chronic ITP

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Fostamatinib (Tavalisse)
Photo courtesy of
Rigel Pharmaceuticals
The US Food and Drug Administration (FDA) has granted approval for the oral SYK inhibitor fostamatinib disodium hexahydrate (Tavalisse™). Fostamatinib is now approved for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Rigel... [Read Article]
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FDA expands approved use of product for VWD

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Recombinant von Willebrand
factor (Vonvendi)
Photo courtesy of Shire
The US Food and Drug Administration (FDA) has expanded the approved use of Vonvendi, a recombinant von Willebrand factor product. Vonvendi is now approved for perioperative management of bleeding in adults (age 18 and older) with von Willebrand disease (VWD). Vonvendi was previously FDA-approved... [Read Article]
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Generic melphalan available in US

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Fresenius Kabi’s Melphalan
Hydrochloride for Injection
Photo from Business Wire
Fresenius Kabi’s Melphalan Hydrochloride for Injection, a generic version of Alkeran®, is now available in the US. Melphalan Hydrochloride for Injection is available as a 2-vial kit containing 1 single-dose vial of melphalan hydrochloride equivalent to 50 mg of melphalan and 1 vial of... [Read Article]
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Health Canada approves product for adult ALL

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Micrograph showing ALL
Health Canada has approved inotuzumab ozogamicin (Besponsa™) as monotherapy for adults with relapsed or refractory, CD22-positive, B-cell precursor acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin is the first and only CD22-directed antibody-drug conjugate approved for this indication. The product consists of a monoclonal antibody targeting CD22 and a cytotoxic agent known as calicheamicin.... [Read Article]
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Drug receives priority review for HCL

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Hairy cell leukemia
Image from Paulo
Henrique Orlandi Mourao
The US Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin. With this BLA, AstraZeneca is seeking approval for moxetumomab pasudotox for the treatment of adults with hairy cell leukemia... [Read Article]
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EC expands indication for denosumab to MM

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Vials of drug
Photo by Bill Branson
The European Commission (EC) has approved an expanded indication for denosumab (Xgeva). The drug is now approved for the prevention of skeletal-related events (SREs) in adults with advanced malignancies involving bone, which includes patients with multiple myeloma (MM). Approval from the EC provides a centralized marketing authorization with... [Read Article]
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Drug nets orphan designation for SCD

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A sickled red blood cell
beside a normal one
Image by Betty Pace
The European Commission (EC) has granted orphan designation to Altemia (formerly SC411) for the treatment of pediatric patients with sickle cell disease (SCD). Altemia gelatin capsules are designed to replenish the lipids destroyed by sickle hemoglobin. Altemia is intended to be... [Read Article]
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FDA approves blinatumomab to treat MRD+ BCP-ALL

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Vials of blinatumomab powder
and solution for infusion
Photo courtesy of Amgen
The US Food and Drug Administration (FDA) has expanded the approved indication for blinatumomab (Blincyto®). The drug is now approved to treat adults and children with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in first or second complete remission (CR) with minimal residual... [Read Article]
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Drug receives orphan designation for AML

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Micrograph showing AML
Image from Paulo
Henrique Orlandi Mourao
The US Food and Drug Administration (FDA) has granted orphan designation to MAX-40279 for the treatment of acute myeloid leukemia (AML). MAX-40279 is a multi-target kinase inhibitor being developed by MaxiNovel Pharmaceuticals, Inc. The drug mainly targets FMS-related tyrosine kinase 3 (FLT3) and fibroblast growth... [Read Article]
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