EMA PRIME Wins For Bispecific Antibodies & Another Gene Therapy
Just three of the 13 applications that the European Medicines Agency most recently reviewed for entry onto its priority medicines scheme made the grade.
You may also be interested in...
Three requests for the accelerated assessment of planned EU marketing applications were considered by the European Medicines Agency last month.
Companies find it challenging when it comes to preparing robust quality data packages for their marketing applications for investigational products that have made it onto the European Medicines Agency’s popular priority medicines scheme.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.