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 ...

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, ...

The US Food and Drug Administration has accepted Sobi’s supplemental biologics licence application for Gamifant ...

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 (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review ...

announced today the resubmission of its Biologics License Application (BLA) for ONS-5010 to the U.S. Food and Drug Administration (FDA). The company, which specializes in the development of ...

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

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

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