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
GSK has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its B-cell inhibiting monoclonal antibody Benlysta (belimumab) to potentially treat systemic sclerosis (SSc).
The recombinant adeno-associated virus (rAAV)-based gene therapy is being studied to treat neovascular Age Related Macular Degeneration (nAMD), which causes severe loss of vision and irreversible blindness across
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