Pharmacy
News
EC approves new use, formulation of dasatinib
The European Commission (EC) has expanded the marketing authorization for dasatinib (Sprycel). The drug is now approved to treat patients ages 1...
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CHMP recommends CAR T for ALL, DLBCL
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of tisagenlecleucel (Kymriah®,...
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CHMP recommends CAR T for DLBCL, PMBCL
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the chimeric antigen receptor (...
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CHMP backs expanded approval of tocilizumab
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approved use of tocilizumab (...
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EC grants blinatumomab full approval
The European Commission (EC) has granted a full marketing authorization for blinatumomab (BLINCYTO®) as a treatment for adults with Philadelphia...
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PU-H71 receives orphan drug designation for myelofibrosis
The US Food and Drug Administration (FDA) has granted orphan drug designation to PU-H71 to treat patients with myelofibrosis. The drug...
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FDA grants pembrolizumab accelerated approval for PMBCL
The US Food and Drug Administration (FDA) granted accelerated approval to the anti-PD-1 therapy pembrolizumab (Keytruda) for the treatment of...
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Mircera approved for anemia in pediatric patients with CKD
Mircera®, methoxy polyethylene glycol-epoetin beta, was approved by the US Food and Drug Administration (FDA) to treat anemia in pediatric...
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FDA approves venetoclax for CLL/SLL with or without del 17p
The US Food and Drug Administration (FDA) has approved venetoclax tablets (Venclexta ®) in combination with rituximab to treat patients with...
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Emicizumab granted priority review for hemophilia A without inhibitors
The US Food and Drug Administration (FDA) has granted priority review for emicizumab (Hemlibra®) for adults and children with hemophilia A without...
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FDA approves first biosimilar pegfilgrastim
The US Food and Drug Association (FDA) has approved pegfilgrastim-jmdb (Fulphila™) as the first biosimilar to Neulasta®. The agents reduce the...