Pharmacy
News
CHMP backs approval of dasatinib for kids
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended changes to the marketing authorization for...
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CHMP recommends approval for generic carmustine
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Carmustine Obvius, a...
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GO approved to treat AML in Europe
The European Commission has authorized use of gemtuzumab ozogamicin (GO, Mylotarg™) as a treatment for patients with acute myeloid leukemia (AML...
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Idarucizumab receives full FDA approval
The US Food and Drug Administration (FDA) has granted full approval to idarucizumab (Praxbind®), the specific reversal agent for dabigatran...
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Fostamatinib approved to treat adults with chronic ITP
The US Food and Drug Administration (FDA) has granted approval for the oral SYK inhibitor fostamatinib disodium hexahydrate (Tavalisse™)....
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FDA expands approved use of product for VWD
The US Food and Drug Administration (FDA) has expanded the approved use of Vonvendi, a recombinant von Willebrand factor product. Vonvendi is now...
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Generic melphalan available in US
Fresenius Kabi’s Melphalan Hydrochloride for Injection, a generic version of Alkeran®, is now available in the US. Melphalan Hydrochloride for...
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Health Canada approves product for adult ALL
Health Canada has approved inotuzumab ozogamicin (Besponsa™) as monotherapy for adults with relapsed or refractory, CD22-positive, B-cell...
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Drug receives priority review for HCL
The US Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for moxetumomab pasudotox, an...
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EC expands indication for denosumab to MM
The European Commission (EC) has approved an expanded indication for denosumab (Xgeva). The drug is now approved for the prevention of skeletal-...
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Drug nets orphan designation for SCD
The European Commission (EC) has granted orphan designation to Altemia (formerly SC411) for the treatment of pediatric patients with sickle cell...