Pharmacy
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JCAR017 gets PRIME access, breakthrough designation
The chimeric antigen receptor (CAR) T-cell therapy JCAR017 has received breakthrough therapy designation from the US Food and Drug Administration...
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Agios stops developing drug for PK deficiency
Agios Pharmaceuticals, Inc.
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CHMP recommends authorization of rituximab biosimilar
Photo by Linda Bartlett The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the rituximab...
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Health Canada approves therapy for hemophilia A
Health Canada has approved the use of lonoctocog alfa (Afstyla), a recombinant factor VIII (FVIII) single-chain therapy, in hemophilia A patients...
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EC authorizes new use for ofatumumab in CLL
Photo courtesy of GSK The European Commission (EC) has granted marketing authorization for ofatumumab (Arzerra®) to be used in combination with...
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EC grants venetoclax conditional approval for CLL
(US version, Venclexta) Photo courtesy of Abbvie The European Commission (EC) has granted conditional marketing authorization for the oral BCL-2...
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FDA grants priority review to sBLA for pembrolizumab
Photo courtesy of Merck The US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (...
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NICE recommends pomalidomide for routine use
Photo from Business Wire The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination recommending...
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EC grants drug orphan designation for SCD
beside a normal one Image by Betty Pace The European Commission (EC) has designated GBT440 as an orphan medicinal product for the treatment of...
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NICE recommends taking ibrutinib off CDF
Photo courtesy of Janssen The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination recommending...
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FDA grants full approval for ponatinib
Photo from Business Wire The US Food and Drug Administration (FDA) has granted full approval for the kinase inhibitor ponatinib (Iclusig®) and...