News about "Roche"

US FDA Approves Roche's Lunsumio VELO for Subcutaneous Use in Follicular Lymphoma

The US FDA has approved Roche’s Lunsumio VELO for subcutaneous use in Relapsed or Refractory Follicular Lymphoma, cutting administration time to about one minute and supported by strong complete response data in later-line patients.

Roche | 22/12/2025 | By News Bureau

Takeda Becomes a BaseLaunch Partner

BaseLaunch has added Takeda as a new pharmaceutical partner to its biotech venture incubator, expanding its network of global pharma backers supporting and funding early-stage drug development startups.

Roche | 19/12/2025 | By News Bureau

Roche Secures FDA CLIA Waiver and CE Mark for Bordetella POC Test

Roche has received CE Mark approval for its first point-of-care test capable of diagnosing and differentiating Bordetella infections, including whooping cough, within 15 minutes. The rapid, PCR-accurate test enables faster clinical decisions and supports early intervention, particularly for vulnerable groups such as infants and the elderly.

Roche | 03/12/2025 | By Dineshwori |  151

Roche's Fenebrutinib Delivers Strong Phase III results as a Potential First-in-Class BTK Inhibitor for Multiple Sclerosis

In the pivotal FENtrepid trial, Roche’s BTK inhibitor fenebrutinib demonstrated a meaningful reduction in disability progression in Primary Progressive Multiple Sclerosis (PPMS), performing at least on par with OCREVUS—the current standard and only approved treatment for PPMS.

Roche | 15/11/2025 | By Dineshwori |  100

Roche's Gazyva/Gazyvaro Shows Positive Results for Systemic Lupus Erythematosus in Phase III trials

The ALLEGORY study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva/Gazyvaro versus standard therapy.

Roche | 05/11/2025 | By Dineshwori |  135

Roche Receives CE Mark for Elecsys Dengue Antigen Test, Enhancing Global Diagnostic Capabilities

This milestone represents a significant advancement in efficiency and reliability for laboratories worldwide, helping healthcare systems address the escalating global dengue crisis.

Roche | 30/10/2025 | By Darshana |  192

Roche receives CE Mark for AI-based Kidney Klinrisk Algorithm

The new CKD algorithm panel, available on the Navify Algorithm Suite, marks a step in Roche’s strategy to provide digital health solutions for the growing global burden of CKD.

Roche | 07/10/2025 | By Dineshwori |  223

Roche Reports Positive Results from Phase III evERA Breast Cancer Study

Roche has announced positive results from the phase III evERA study evaluating its investigational oral selective oestrogen receptor degrader (SERD), giredestrant, in combination with everolimus in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.

Roche | 24/09/2025 | By Dineshwori |  115

Roche to Acquire 89bio in Deal Worth Up to USD 3.5 Billion

Roche has entered into a merger agreement to acquire 89bio, a San Francisco-based clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardiometabolic diseases.

Roche | 18/09/2025 | By Dineshwori |  168

Pfizer, Novartis, Roche Lead Net-Zero Pharma Supply Chain Transition

Europe currently dominates the global net-zero pharma supply chain market supported by strict climate regulations, while Asia-Pacific is the fastest-growing region, spurred by new government-led sustainability policies.

Roche | 11/09/2025 | By Dineshwori |  452