Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® ...
Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients ...
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva®) for the treatment of ...
Roche's filing is based on data from a late-stage study that shows a complete renal response benefit in lupus nephritis patients who received Gazyva.
Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License ...
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for ...
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for ...
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License ...
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit1 The filing application is based on data from the phase ...
Phase III PRESTIGE-AF trial shows that direct oral anticoagulants significantly lower the risk of ischemic stroke in ...
For patients with active lupus nephritis, obinutuzumab, a humanized type II anti-CD20 monoclonal antibody plus standard ...
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