Pharmacy
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FDA approves first drug for polycythemia vera
Credit: AFIP The US Food and Drug Administration (FDA) has expanded the approved use of ruxolitinib (Jakafi) to include treatment of patients...
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NICE reconsiders obinutuzumab for CLL
Credit: Linda Bartlett The UK’s National Institute for Health and Care Excellence (NICE) has issued a draft guidance that recommends obinutuzumab...
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FDA approves first anti-CD19 drug
Credit: NIAID The US Food and Drug Administration (FDA) has granted accelerated approval for blinatumomab (Blincyto) to treat adults with...
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Drug gets orphan designation for MM & CLL/SLL
The European Medicines Agency (EMA) has granted orphan drug designation for selinexor (KPT-330) to treat multiple myeloma (MM) and chronic...
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FDA grants drug orphan designation for AML
Actimab-A consists of the CD33 antibody lintuzumab linked to the actinium-225 payload.
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NICE offers conditional support for eculizumab
Credit: Globovision The UK’s National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending eculizumab (...
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NICE expands use of ESAs in cancer patients
chemotherapy Credit: Rhoda Baer The UK’s National Institute for Health and Care Excellence (NICE) has updated its guidance to expand the use of...
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Drug dubbed ‘breakthrough’ for AL amyloidosis
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for the oral proteasome inhibitor ixazomib (MLN9708) to...
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Health Canada expands indication for apixaban
Credit: Andre E.X.
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FDA influence on design of pivotal drug studies
Credit: FDA New research suggests that 20% of recent drug approvals occurred without pharmaceutical companies and the US Food and Drug...
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CAR T-cell therapy gets breakthrough designation
Credit: Charles Haymond The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for JCAR015, a chimeric antigen...