Incyte/MorphoSys Await EU Verdict On Tafasitamab For DLBCL
Updated Results From Monoclonal Antibody’s Phase II Trial Released In June
Is the benefit-risk profile of tafasitamab good enough for it to be recommended for EU-wide marketing approval? Codevelopers Incyte and MorphoSys may find out this week.
You may also be interested in...
Sponsors of several new medicines, including the first ever CAR-T for multiple myeloma, will find out this week if their products are on track to get EU marketing authorizations. Also, three sponsors might be asked to address outstanding issues about their products in the final stages of review.
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.
Bristol Myers Squibb's marketing application for liso-cel is in the final stages of the review process at the European Medicines Agency. The agency’s drug evaluation committee, the CHMP, adopted in mid-April the list of concerns it has with the application.