Roche receives FDA authorisation for testing of asymptomatic people with the cobas SARS-CoV-2 Test to help control the spread of COVID-19
The high-throughput, highly sensitive cobas SARS-CoV-2 Test under FDA Emergency Use Authorisation can now be used to test individual or pooled samples from people without symptoms or other reasons to suspect COVID-19
Accurate, reliable and early detection of SARS-CoV-2 in potentially exposed individuals can help limit the spread of disease
PLEASANTON, Calif., May 18, 2021 /PRNewswire/ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its
cobas SARS-CoV-2 Test for use on the widely available, high-throughput
cobas 6800/8800 Systems has received Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA) for testing individuals without symptoms or reasons to suspect COVID-19. This authorisation supports the guidance update from the U.S. Centers for Disease Control and Prevention (CDC) to expand SARS-CoV
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Tecentriq significantly improved overall survival in people with high PD-L1 expression, compared with chemotherapy in a Phase III study
Tecentriq
This approval marks
Tecentriq s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall in the EU
Basel, 5 May 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression , with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer, said Levi Garraway, M.D., Ph.D., Roche s Chief Medical Officer and Head of Global Product Development. Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expressi
F. Hoffmann-La Roche Ltd
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
Basel, 28 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 2 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1, as determined by an FDA-approved test. Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not
Search jobs 28-Apr-2021 Roche launches new ways to use their cardiovascular tests empowering clinicians to improve diagnosis and treatment of millions of people
Cardiovascular diseases are responsible for 17.9 million deaths every year¹, a third of all deaths globally²
Roche announces five new intended uses for key cardiac biomarkers to help identify cardiovascular risk, better diagnose patients and support early treatment
Early diagnosis and treatment can contribute to saving or improving people s lives and could help healthcare systems save money
Basel, 28 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced a series of five new intended uses for two key cardiac biomarkers using the Elecsys® technology: high sensitive cardiac troponin T (cTnT-hs) and N-terminal pro-brain natriuretic peptide test (NT-proBNP). These gold standard biomarkers³ have proven to be successful in supporting cardiovascular disease management and c
F. Hoffmann-La Roche Ltd
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for previously untreated metastatic bladder cancer
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for previously untreated metastatic bladder cancer
Basel, 28 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumours express high levels of PD-L1 (PD-L1–stained tumour-infiltrating immune cells covering ≥5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless o