FDA approves Roche’s kidney inflammation drug
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
Vamikibart is the first targeted, non-steroid treatment designed to address the underlying inflammation driving UME
Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study
Importantly, the combination of giredestrant and everolimus was well tolerated
Zilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensives
Roche also shared the design of its upcoming Phase III TRONTIER 1 and 2 trials investigating trontinemab in people with early symptomatic Alzheimer’s disease
Elevidys is currently the only approved gene therapy that targets the root cause of Duchenne
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
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