Pharmacy
News
Blinatumomab granted full approval to treat rel/ref BCP-ALL
The US Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for blinatumomab (Blincyto®). The...
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Benefits of gemtuzumab ozogamicin outweigh risks, ODAC says
The US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) has announced a positive opinion of gemtuzumab ozogamicin (GO...
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FDA grants priority review to sNDA for dasatinib
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for dasatinib (Sprycel)....
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Vaccine granted orphan designation for MDS
The US Food and Drug Administration (FDA) has granted orphan drug designation to DSP-7888, an investigational cancer peptide vaccine, for the...
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FDA approves new treatment for sickle cell disease
The US Food and Drug Administration (FDA) has granted approval for L-glutamine oral powder (Endari), the first treatment approved to treat sickle...
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FDA puts pembrolizumab trials on clinical hold
The US Food and Drug Administration (FDA) has placed clinical holds on 3 trials testing combination therapy with pembrolizumab (Keytruda) in...
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EC approves therapy for relapsed/refractory BCP-ALL
The European Commission (EC) has approved inotuzumab ozogamicin (BESPONSA®) as monotherapy for adults with relapsed or refractory, CD22-positive B...
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FDA unveils plan to eliminate orphan designation backlog
The US Food and Drug Administration (FDA) has unveiled a plan to eliminate the agency’s existing backlog of orphan designation requests and ensure...
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EC grants factor IX therapy orphan designation
The European Commission has granted orphan medicinal product designation to CB 2679d/ISU304, a clinical stage drug candidate for hemophilia B. CB...
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Lower dose of rivaroxaban receives priority review
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for rivaroxaban (XARELTO...
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Betrixaban receives FDA approval for VTE prophylaxis in adults
The oral, once-daily factor Xa inhibitor betrixaban (Bevyxxa®) was granted approval by the US Food and Drug Administration (FDA) under priority...