FDA

Roche Receives FDA 510(k) Clearance for the First Blood Test in the U.S. Measuring Lp(a) in Nolar Units

Roche

COVID-19 Testing

Roche Obtains CE Mark for the SARS-CoV-2 Antigen Self Test Nasal Allowing for Rapid Self Testing of COVID-19 At Home

Roche

Production

Novartis to Produce Roche's Actemra/RoActemra

Novartis

Collaboration

Blueprint Medicines Announces Global Collaboration with Roche to Develop and Commercialize Pralsetinib for Patients with RET-Altered Cancers

Blueprint Medicines

Clinical Trials

New Data from Phase IIIb Study Reinforces Safety Profile of Roche’s Hemlibra in People with Haemophilia A

Roche

COVID-19 Antibody Testing

Roche's Highly Accurate Antibody Test for COVID-19 Goes Live at More than 20 Initial Lab Sites in the U.S.

Roche

FDA Approval

Roche Receives FDA Approval for Cobas HPV Test to Identify Women at Risk for Cervical Cancer

Roche

COVID-19

Roche Initiates Phase III Clinical Trial of Actemra/RoActemra in Patients with Severe COVID-19 Pneumonia

Roche

Roche Ships 400,000 Coronavirus Test Kits to U.S.

Roche

Clinical Trials

Roche’s Risdiplam Meets Primary Endpoint in Pivotal FIREFISH Trial

Roche

M&A

Federal Trade Commission Closes Investigation of Roche Holding AG’s Proposed Acquisition of Spark Therapeutics, Inc.

The Federal Trade Commission

Commercial Agreement

Dicerna™ Enters Agreement with Roche to Develop and Commercialize DCR-HBVS for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

Novo Nordisk

Oncology

Roche Receives CHMP Positive Opinion for New Tecentriq-based Combination Therapy as an Initial Treatment for Most Common Form of Advanced Lung Cancer

Roche

Leadership

Changes in Roche's Board of Directors and Corporate Executive Committee

Roche

Companion Diagnostics

Roche to Develop Companion Diagnostic Test to Help Identify Patients Eligible for Anti-PD-1 Therapy Based on Biomarker Expression, Not Location, of Solid Tumors

Roche

FDA Approval

FDA Approves Roche's Tecentriq in Combination with Avastin and Chemotherapy for the Initial Treatment of People with a Specific Type of Metastatic Lung Cancer

Roche