Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children Data reinforce well-established safety profile […]
The U.S. Food and Drug Administration granted accelerated approval to GlaxoSmithKline’s PD-1 checkpoint inhibitor Jemperli (dostarlimab) for a wider group of indications for adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
The U.S. Food and Drug Administration approved the expansion of Amgen’s Kyprolis (carfilzomib) U.S. prescribing information to include the product’s use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens – once weekly and twice weekly – for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.
The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.
Vertex Pharmaceuticals Incorporated announced that the European Commission granted extension of the Marketing Authorization for Orkambi (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis in people with two copies of the F508del mutation, to include children ages 6 through 11.