FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy
F. Hoffmann-La Roche Ltd Priority Review decision is based on phase III MAJESTY results, where Gazyva/Gazyvaro achieved significantly…
RHHBY’s Gazyva Gets FDA Priority Review for Label Expansion
Roche RHHBY announced that the FDA has granted Priority Review to the company’s supplemental biologics license application (sBLA)…
The Future of Treating Autoimmune Diseases: Science, Tech, & Patients Driving Progress
For millions living with autoimmune diseases, progress has long felt out of reach. Approximately 8% of Americans have…
Roche lupus drug Gazyva gets FDA filing acceptance
Roche (OTCQX: RHHBY) said the FDA accepted its supplemental BLA for Gazyva/Gazyvaro (obinutuzumab)…
Roche lupus drug cuts disease activity in phase III
Roche (OTCQX: RHHBY) announced NEJM publication of phase III ALLEGORY data showing Gazyva/Gazyvaro (obinutuzumab) plus standard therapy significantly…
New England Journal of Medicine publishes phase III ALLEGORY data showing Roche’s Gazyva/Gazyvaro significantly reduces disease activity in the most common form of lupus
Over three quarters of people on Gazyva/Gazyvaro plus standard therapy achieved at least a four-point improvement in SRI-4,…