Pharmacy
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Studies raise concerns about drug approval process
Photo courtesy of the FDA Two newly published studies have raised concerns about the drug approval process in the US. One study showed that,...
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mAb gets priority review as maintenance in CLL
Photo by Linda Bartlett The US Food and Drug Administration (FDA) has granted priority review for an application for ofatumumab (Arzerra) as...
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Gene therapy granted fast track designation for hemophilia B
The US Food and Drug Administration (FDA) has granted fast track designation to a gene therapy product being developed to treat hemophilia B. The...
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MM drugs granted priority review
multiple myeloma The US Food and Drug Administration (FDA) has granted priority review for 4 drugs intended to treat multiple myeloma (MM):...
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FDA approves product for hemophilia A
The US Food and Drug Administration (FDA) has approved the recombinant factor VIII product simoctocog alfa (Nuwiq) for adults and children with...
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EMA recommends orphan designation for LJPC-401
red blood cells Image by Graham Beards The European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) has adopted a...
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EMA recommends orphan designation for CAR T-cell therapy
The European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products has adopted a positive opinion recommending that KTE-C19 receive...
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FDA grants drug orphan designation for hemophilia B
The US Food and Drug Administration (FDA) has granted orphan designation for DTX101 as a treatment for hemophilia B. DTX101 is designed to...
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Scientists describe new way to create etoposide
Scientists have reported a new way to produce the chemotherapeutic agent etoposide, and they believe this discovery could lead to a more stable...
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Drug granted orphan designation for AML
Image by Lance Liotta The investigational therapy SL-401 has received orphan designation to treat acute myeloid leukemia (AML) in the European...
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Blood cancer drugs set to be removed from CDF
Photo courtesy of CDC England’s National Health Service (NHS) plans to remove several drugs used to treat hematologic malignancies from the...