FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer

The NDA filing is supported by results from the phase III evERA Breast Cancer study

Roche’s Gazyva hits major milestone in rare kidney disease

Primary membranous nephropathy is a chronic autoimmune disease that attacks the kidneys’ filtering units

Roche BTK drug emerges as potential breakthrough in primary progressive MS

Roche’s investigational obesity drug CT-388 delivers dramatic weight loss in Phase II trial

The Phase III programme, Enith1 and Enith2, is expected to launch this quarter

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

Full approval will depend on verification of clinical benefit in a confirmatory trial

New oral SERD from Roche delivers significant survival edge in early breast cancer

At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival

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

Roche’s Columvi combo doubles survival in hard-to-treat lymphoma

Columvi combined with gemcitabine and oxaliplatin dramatically extends survival in people with relapsed or refractory diffuse large B-cell lymphoma

Roche wins EU green light for one-minute injection cancer therapy

Roche’s Giredestrant sets new benchmark in early breast cancer treatment

The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in invasive disease-free survival