The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for ...

Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients ...

US FDA accepts Roche’s Gazyva/Gazyvaro sBLA for the treatment of lupus nephritis: Basel Thursday, March 6, 2025, 09:00 Hrs [IST] Roche announced that the US Food and Drug Admini ...

The US regulator has started a review of Roche's supplemental biologics license application (BLA) for Gazyva/Gazyvaro ...

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 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.

Genentech, a Roche Group company(OTCQX:RHHBY) said on Wednesday that the U.S. FDA accepted the company’s supplemental ...

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

Phase 1 Dose Expansion Initiated for FT819 Off-the-Shelf CAR T-cell Product Candidate with Fludarabine-free Conditioning in ...

The decision to acquire Chimerix comes just a few months after Jazz claimed FDA approval for Ziihera (zanidatamab), its ...