Immunocore and Argenx Among Fast-Track Hopefuls At EMA
Five Accelerated Assessment Decisions Due, Including On Tebentafusp And Efgartigimod
EU reviewers will decide this week whether to grant accelerated assessment to a handful of new dug candidates that will soon be filed for approval.
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EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency.
The European Medicines Agency will decide this week whether BMS and bluebird bio’s cell-based gene therapy for multiple myeloma should be approved for use in the EU.
The launch of efgartigimod at the end of 2021 is very much Argenx's focus now that J&J is terminating their alliance for the anti-CD70 antibody cusatuzumab for acute myeloid leukemia "in consideration of the evolving standard of care" for the disease.