Pharmacy
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EC grants immunotherapy orphan designation
among uninfected cells (blue) Image courtesy of Benjamin Chaigne-Delalande The European Commission (EC) has granted orphan drug designation for...
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Ibrutinib approved for first-line treatment of CLL
Photo courtesy of Janssen Health Canada has approved the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica®) as a first-line treatment for...
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FDA rejects pegfilgrastim biosimilar
The US Food and Drug Administration (FDA) has decided not to approve Novartis’s application for a biosimilar of Amgen’s Neulasta, also known by...
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EC approves lenalidomide for rel/ref MCL
The European Commission (EC) has approved lenalidomide (Revlimid®) for the treatment of adults with relapsed or refractory mantle cell lymphoma (...
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FDA lifts hold on phase 2 JCAR015 trial
Image from NIAID The US Food and Drug Administration (FDA) has removed the clinical hold on the phase 2 ROCKET trial, a study of the chimeric...
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COMP recommends orphan status for drug to treat PNH
The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending orphan designation for...
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EMA reviewing hemophilia A products
The European Medicines Agency (EMA) has started a review of medicines containing factor VIII (FVIII) to assess the risk of inhibitor development...
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Drug’s benefits outweigh risks, PRAC says
Photo courtesy of Gilead Sciences, Inc. The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its...
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Deaths prompt clinical hold for JCAR015 trial
Update: The hold on this trial has been lifted. Click here for additional details. A trial of the chimeric antigen receptor (CAR) T-cell therapy...
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NICE recommends approval for bosutinib
Photo courtesy of CDC The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending approval for...
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EC extends marketing authorization for brentuximab vedotin
Photo from Business Wire The European Commission (EC) has extended the current conditional marketing authorization of brentuximab vedotin (...