Pharmacy
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EC grants gene therapy orphan designation for hemophilia A
The European Commission (EC) has granted orphan designation to BMN 270, an investigational gene therapy, for the treatment of patients with...
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mAb gets breakthrough designation for HLH
Photo by Linda Bartlett The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to NI-0501 for the treatment of...
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EMA recommends safety measures for idelalisib
Photo courtesy of Gilead Sciences, Inc. In light of recently reported safety concerns, the European Medicines Agency’s (EMA) Pharmacovigilance...
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FDA rejects ready-to-use bivalirudin formulation
Image by Kevin MacKenzie The US Food and Drug Administration (FDA) has said it cannot, at present, approve a ready-to-use (RTU) formulation of...
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FDA approves product for hemophilia A
Photo by Bill Branson The US Food and Drug Administration (FDA) has approved the recombinant antihemophilic factor Kovaltry for the treatment of...
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FDA approves drug for 2 indications in MM
Photo courtesy of Spectrum Pharmaceuticals The US Food and Drug Administration (FDA) has approved a new formulation of melphalan for injection (...
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Idelalisib trials stopped due to AEs
Photo courtesy of Gilead Sciences The US Food and Drug Administration (FDA) has reported that Gilead Sciences, Inc., is stopping 6 clinical...
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Drug granted orphan designation for DLBCL
The US Food and Drug Administration (FDA) has granted orphan designation to the oncology drug candidate PNT2258 for the treatment of diffuse large...
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AEs prompt EMA review of idelalisib
Photo courtesy of Gilead Sciences, Inc. The European Medicines Agency (EMA) is reviewing the safety of idelalisib (Zydelig), a drug approved to...
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Program can predict drug side effects
Photo by Darren Baker Scientists say they have developed a computer program that can predict whether or not a given pharmaceutical agent will...
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FDA lifts partial clinical hold on pidilizumab
The US Food and Drug Administration (FDA) has lifted the partial clinical hold on the investigational new drug (IND) application for pidilizumab (...