Pharmacy
News
EMA initiative aims to accelerate drug development
Photo courtesy of the FDA The European Medicines Agency (EMA) has launched PRIME (PRIority MEdicines), an initiative intended to accelerate the...
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FDA approves long-acting hemophilia B therapy
The product—a fusion protein linking recombinant coagulation factor IX with recombinant albumin—is intended for use in children and adults for...
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FDA approves ibrutinib as first-line CLL therapy
Photo courtesy of Janssen The US Food and Drug Administration (FDA) has approved the BTK inhibitor ibrutinib (Imbruvica) as a first-line...
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Gene therapy granted orphan designation for hemophilia A
Image courtesy of NHLBI The US Food and Drug Administration (FDA) has granted orphan designation to BMN 270, an investigational gene therapy, for...
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EC approves drug for iron-deficiency anemia in IBD
The European Commission (EC) has granted marketing authorization for ferric maltol (Feraccru) to treat iron-deficiency anemia in adults with...
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Drug granted orphan designation for hemolytic anemia
The European Commission (EC) has granted orphan drug designation for TNT009 to treat autoimmune hemolytic anemia, including cold agglutinin...
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CHMP recommends fusion protein for hemophilia B
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that albutrepenonacog alfa (Idelvion)...
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EC grants venetoclax orphan designation for AML
The European Commission has granted orphan drug designation for the oral BCL-2 inhibitor venetoclax to treat acute myeloid leukemia (AML). The EC...
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FDA approves obinutuzumab for FL
The US Food and Drug Administration (FDA) has approved obinutuzumab (Gazyva) for certain patients with previously treated follicular lymphoma (FL...
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Orphan designation recommended for BTK inhibitor
The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) is recommending orphan designation for the second-generation BTK...
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FDA investigates issues with rivaroxaban trial
The US Food and Drug Administration (FDA) is investigating issues surrounding a defect in the device that was used to test international...