Pharmacy
News
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-...
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Health Canada expands approval of obinutuzumab
Health Canada has expanded the approved use of obinutuzumab (Gazyva®). The anti-CD20 monoclonal antibody is now approved for use in combination...
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Conflicts of interest among FDA advisers
An investigative report has unearthed potential conflicts of interest among physicians who serve on advisory panels for the US Food and Drug...