Genentech, a member of Roche (RHHBY), announced that the FDA has accepted the company’s supplemental biologics license application for Gazyva ...

Companies in the Healthcare sector have received a lot of coverage today as analysts weigh in on Roche Holding AG (RHHVF – Research Report) ...

A regulatory decision is expected by October 2025. The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva ®) for the ...

The price you pay for Gazyva depends on factors such as your dosage, whether you have health insurance, and the pharmacy you use. Financial assistance may be available to help you with the cost of ...

– Gazyva is the only anti-CD20 monoclonal antibody in a randomized Phase III study to demonstrate a complete renal response benefit – – The filing application is based on data from the Phase ...

Roche's anti-CD20 antibody Gazyva has been on the market for more than a decade as a treatment for blood cancer, but could see a new lease of life if it gets FDA approval to treat kidney disease ...

Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of ...

At 76 weeks, complete renal response rates were 46.4% with obinutuzumab and 33.1% with placebo. Serious adverse events were more common with obinutuzumab than placebo. Adding obinutuzumab to ...