Drugs & Targets

Drugs & Targets

European Commission Approves Unituxin In Pediatric High-Risk Neuroblastoma

The European Commission granted a marketing authorization for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation. Unituxin is administered in combination with granulocyte-macrophage colony-stimulating factor,... […]
Drugs & Targets

Amgen submits sNDA for Kyprolis for Injection

Amgen submitted a supplemental New Drug Application to the FDA for Kyprolis (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is based on data from the global ENDEAVOR trial. ENDEAVOR is the first of two head-to-head... […]