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® ...
The US Food and Drug Administration (FDA) has accepted the 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 ...
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 Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva®) for the treatment of ...
Genentech, a Roche Group company(OTCQX:RHHBY) said on Wednesday that the U.S. FDA accepted the company’s supplemental ...
UK-based Trimtech Therapeutics, a biotech harnessing targeted protein degradation (TPD) for neurodegenerative diseases, has ...