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

The U.S. Food and Drug Administration (FDA) has accepted Genentech’s 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 ...

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

Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License ...

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 FDA has accepted for Priority Review the BLA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis.

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for depemokimab for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps ...

Ocugen Inc (OCGN) outlines pivotal trial progress and financial strategies while navigating increased expenses and market ...

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

VerifiedEmail solves a challenge every online business faces: ensuring every email reaches its intended recipient. Born from our struggles with email deliverability, VerifiedEmail swiftly and ...

Ocugen, Inc.'s stock dropped 2.8% during Wednesday's session but bounced back in extended trading after the company posted a ...