Pharmacy
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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...
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Over 1100 new meds, vaccines being developed to treat cancer
Currently, 1,120 new medicines and vaccines are being developed to treat cancer, according to a new report of the Pharmaceutical Research and...
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Eltrombopag receives priority review designation for SAA
Eltrombopag (Promacta®) in combination with standard immunosuppressive therapy (IST) has received priority review designation from the US Food and...
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FDA grants priority review to gilteritinib for R/R AML
The US Food and Drug Administration (FDA) has granted priority review to gilteritinib for the treatment of adult patients with relapsed or...
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Drug makers may be blocking generic competition
The US Food and Drug Administration (FDA) has released a list of companies that “may be pursuing gaming tactics to delay generic competition.”...
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FDA approves first epoetin alfa biosimilar
The US Food and Drug Administration (FDA) has approved epoetin alfa-epbx (Retacrit), a biosimilar to epoetin alfa (Epogen/Procrit). Epoetin alfa-...
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Galinpepimut-S receives orphan designation for MM
The US Food and Drug Administration (FDA) has granted orphan drug designation to galinpepimut-S (GPS) as a treatment for multiple myeloma (MM)....
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Daratumumab approved for newly diagnosed MM
The US Food and Drug Administration (FDA) has granted another approval for the CD38-directed antibody daratumumab (Darzalex®). Daratumumab is now...
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Cost of imatinib still high despite generic options, team says
The availability of generic imatinib has had limited effects on costs of the drug, according to research published in Health Affairs. Data...
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FDA approves antidote for factor Xa inhibitors
The US Food and Drug Administration (FDA) has granted accelerated approval for andexanet alfa (Andexxa®), the first antidote for the reversal of...