News about "Roche"

Roche's Gazyva Receives US FDA Priority Review for Membranous Nephropathy

The US Food and Drug Administration (FDA) has granted Priority Review to Roche's Gazyva for primary membranous nephropathy, supported by phase 3 MAJESTY trial results showing superior complete remission versus tacrolimus.

Roche | 17/07/2026 | By News Bureau

Roche Receives CE Mark for Automated Blood Test to Detect Latent Tuberculosis Infection

Roche's Elecsys IGRA TB test enables tuberculosis infection screening with results in under 24 hours, offering faster laboratory workflows and supporting efforts to improve TB diagnosis and control.

Roche | 10/07/2026 | By News Bureau |  120

Roche's Divarasib Outperforms First-Generation KRAS G12C Inhibitors in Phase 3 Lung Cancer Trial

Roche's investigational KRAS G12C inhibitor divarasib demonstrated superior progression-free and overall survival over approved first-generation therapies in the Phase III Krascendo 1 trial, marking a significant advance in the treatment of previously treated KRAS G12C-mutated non-small cell lung cancer.

Roche | 04/07/2026 | By News Bureau |  177

Roche's Divarasib Outperforms KRAS G12C Inhibitors in Phase 3 NSCLC Trial

Roche’s divarasib demonstrated superior Progression-Free Survival over approved KRAS G12C inhibitors in the phase 3 Krascendo-1 trial for previously treated advanced Non-Small Cell Lung Cancer (NSCLC).

Roche | 02/07/2026 | By News Bureau

Roche's Enspryng Receives FDA Priority Review for Thyroid Eye Disease

Roche's Enspryng has received FDA Priority Review for thyroid eye disease after Phase 3 studies demonstrated clinically meaningful improvements in eye bulging, disease activity and double vision, with a regulatory decision expected by October 2026.

Roche | 01/07/2026 | By News Bureau

Roche Launches AXELIOS 1 Sequencing Platform Powered by Proprietary SBX Technology

Roche’s AXELIOS 1, designed for research use, delivers rapid, accurate and scalable genomic sequencing, enabling researchers to accelerate discoveries across oncology, genetics, infectious diseases and other areas of biomedical research.

Roche | 30/06/2026 | By News Bureau |  104

US FDA Accepts Roche's Lunsumio-Polivy Filing for Relapsed Large B-Cell Lymphoma

The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application for the Lunsumio and Polivy combination in relapsed or refractory large B-cell lymphoma. The filing is supported by Phase 3 SUNMO study data showing a 59 percent reduction in the risk of disease progression or death.

Roche | 19/06/2026 | By News Bureau

Roche and Nurix Partner to Develop BTK Degrader Bexobrutideg

Roche and Nurix Therapeutics have partnered to develop and commercialise bexobrutideg, a potential best-in-class BTK degrader for B-cell malignancies, chronic spontaneous urticaria, and Multiple Sclerosis (MS), aiming to overcome resistance to current BTK inhibitors.

Roche | 09/06/2026 | By News Bureau |  110

Roche Receives CE Mark for Blood-Based Alzheimer's Diagnostic Test

Roche receives CE Mark approval for Elecsys pTau217, a blood-based Alzheimer’s diagnostic test developed with Eli Lilly, aimed at enabling earlier and less invasive detection of amyloid pathology in patients with cognitive decline.

Roche | 13/05/2026 | By News Bureau

Roche Reports Strong Phase III Results for Fenebrutinib in Multiple Sclerosis

Roche’s investigational drug fenebrutinib shows significant reduction in relapse rates and disease activity in multiple sclerosis, offering potential for improved long-term outcomes in patients.

Roche | 23/04/2026 | By News Bureau |  133