Pharmacy
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Ponatinib approved in Australia
The Therapeutic Goods Administration (TGA) has approved marketing of ponatinib (Iclusig) in Australia. The drug is now approved to treat adults...
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FDA grants drug orphan designation for aHUS
Credit: Kevin MacKenzie The US Food and Drug Administration (FDA) has granted orphan drug designation for CCX168, an oral inhibitor targeting the...
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FDA grants drug orphan designation for AML
Credit: Lance Liotta The US Food and Drug Administration (FDA) has granted orphan drug designation for the Axl inhibitor BGB324 to treat acute...
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FDA grants CAR T-cell therapy orphan designation
The US Food and Drug Administration (FDA) has granted orphan drug designation for the chimeric antigen receptor (CAR) T-cell therapy JCAR015 to...
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Product approved for hemophilia A in Canada, Australia
Health Canada and Australia’s Therapeutic Goods Administration (TGA) have both approved a recombinant FVIII product known as simoctocog alfa (...
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Hematology drugs on the fast track
Credit: Bill Branson The US Food and Drug Administration (FDA) has granted fast track designation to two hematology drugs: the monoclonal...
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NICE recommends ofatumumab in CLL
Credit: Linda Bartlett The UK’s National Institute for Health and Care Excellence (NICE) has issued a preliminary draft guidance recommending...
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FDA lifts clinical hold on imetelstat
The hold, which was placed in March, suspended a phase 2 study of imetelstat in patients with essential thrombocythemia (ET) or polycythemia vera...
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NICE recommends dabigatran for DVT, PE
Credit: NHS The UK’s National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending dabigatran etexilate (...
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EMA grants product orphan status for AML
The EMA and the US Food and Drug Administration previously granted Atir orphan status for the prevention of acute graft-vs-host-disease (GVHD)...
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Drug gets orphan status for PNH in US
The US Food and Drug Administration (FDA) has granted the complement inhibitor AMY-101 orphan status as a treatment for paroxysmal nocturnal...