Drug Approval | December 11, 2025
Roche secures European nod for Gazyva/Gazyvaro in Lupus Nephritis patients
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
Data show adjuvant Verzenio plus endocrine therapy extends overall survival and sustains long-term improvements in invasive disease-free survival
Developed in partnership with the Johns Hopkins Applied Physics Laboratory (APL), the module is built around a multi-segment RT-PCR method with integrated indexing
Sepsis is a life-threatening reaction to infection that overwhelms the body’s defenses
False positive rates?ranged from 0% to 41%, meaning some labs incorrectly identified bacteria that weren’t present in the sample
Cardiovascular disease (CVD) is the leading cause of death in the US and worldwide with over 82 million Americans living with CVD
Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA
Building a transparent, data-driven supply chain and self-reliant API ecosystem remains critical to reducing import dependence
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
Roche will unveil the primary results from the phase III evERA Breast Cancer study evaluating giredestrant
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