News about "Roche"

Roche's Elecsys pTau217 Gets US FDA Clearance for Alzheimer's Assessment

Roche’s Elecsys pTau217 receives US Food and Drug Administration (FDA) clearance as a blood test for Alzheimer’s amyloid pathology assessment across primary and specialty care settings.

Roche | 25/08/2026 | By News Bureau

Roche's Genentech Expands US Manufacturing Operations

Roche’s Genentech expands US manufacturing with a new Hillsboro, Oregon facility for assembling injectable medicines and delivery devices.

Roche | 21/08/2026 | By News Bureau

CHMP Recommends EU Approval of Roche's Susvimo

The Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of Roche's Susvimo, the first continuous delivery treatment offering an alternative to regular eye injections for wet Age-related Macular Degeneration (AMD).

Roche | 25/07/2026 | By News Bureau

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 |  127

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 |  168

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 |  241

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 |  106

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 |  107

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 |  158

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 |  113