CHMP recommends approval of Bristol Myers Squibb’s Reblozyl
The European Commission (EC) will now review the recommendation. On receiving approval, this would represent the third authorised indication for the therapy in the EU. Approved in the
The adeno-associated viral serotype rh10 (AAVrh10) gene therapy FBX-101 is delivered intravenously after hematopoetic stem cell transplant (HSCT) infusion. The designation for this lead adeno-associated virus (AAV) drug
The regulatory acceptance of application for marketing authorisation of tislelizumab is to treat first-line unresectable or metastatic HCC patients. The humanised IgG4 anti-PD-1 monoclonal antibody tislelizumab has been