News about "Levi Garraway"

US FDA Grants Priority Review to Genentech?s Enspryng for MOGAD

The US Food and Drug Administration (FDA) has granted priority review to Genentech’s Enspryng for MOGAD after phase 3 METEOROID data showed a 68 percent reduction in relapse risk.

Levi Garraway | 11/09/2026 | 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).

Levi Garraway | 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.

Levi Garraway | 17/07/2026 | By News Bureau |  132

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.

Levi Garraway | 04/07/2026 | By News Bureau |  248

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).

Levi Garraway | 02/07/2026 | By News Bureau |  115

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.

Levi Garraway | 01/07/2026 | By News Bureau |  111

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.

Levi Garraway | 19/06/2026 | By News Bureau |  115

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.

Levi Garraway | 09/06/2026 | By News Bureau |  148

US FDA Accepts NDA for Genentech's Giredestrant in ER-Positive Early-Stage Breast Cancer

The US FDA has accepted Genentech’s New Drug Application (NDA) for giredestrant, an investigational oral SERD for ER-positive early-stage breast cancer. Supported by positive phase 3 trial results, giredestrant is the first and only oral SERD to demonstrate efficacy in the curative setting.

Levi Garraway | 03/06/2026 | By News Bureau |  100

Roche's Fenebrutinib Shows Promise in Third Phase III MS Trial

Roche reported positive Phase III FENhance 1 results, with fenebrutinib reducing relapses by 51 percent in relapsing multiple sclerosis, consistent with prior FENhance 2 and FENtrepid data. The company plans regulatory submissions, positioning fenebrutinib as a potential first-in-class BTK inhibitor for relapsing and primary progressive MS.

Levi Garraway | 02/03/2026 | By News Bureau |  241