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

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal ...

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

In the SWIFT and ANCHOR trials, depemokimab demonstrated statistically significant reductions in nasal polyp size, ...

Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number ...

We remain committed to bringing an ophthalmic bevacizumab to market in the United States and providing retina patients suffering from wet AMD with a much needed treatment option that has the potential ...

Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics ...

Gazyva/Gazyvaro is an anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a CRR benefit in lupus ...

Image Source: Zacks Investment Research ADMA’s supplemental biologics license applications (sBLAs) for both Asceniv and Bivigam were approved by the FDA last year. This extended the approved ...

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

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 ...

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...