Pharmacy
News
Health Canada approves emicizumab
Health Canada has approved emicizumab (Hemlibra®) for use as routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A patients...
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CHMP recommends generic deferiprone
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Deferiprone Lipomed to treat...
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CHMP backs generic lenalidomide
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Lenalidomide Accord as a...
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CHMP recommends expanded approval for daratumumab
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing...
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CHMP announces 2 opinions on blinatumomab
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has released 2 new opinions regarding blinatumomab (Blincyto...
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CHMP supports expanded approval for epoetin alfa products
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the terms of marketing...
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CHMP backs 2 biosimilar pegfilgrastim products
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 pegfilgrastim biosimilar...
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CHMP issues final negative opinion of betrixaban
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reiterated its negative opinion of betrixaban. Once...
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CHMP recommends expanded approval for rivaroxaban
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a new indication for rivaroxaban (Xarelto) 2...
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FDA approves drug for IDH1-mutated AML
The US Food and Drug Administration (FDA) has granted full approval for the isocitrate dehydrogenase-1 (IDH1) inhibitor ivosidenib (Tibsovo®)....
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Breakthrough drugs approved with less stringent criteria
Clinical trials supporting the approval of drugs with breakthrough therapy designation1 do not meet the same standards as trials for non-...