FDA approves Roche’s Vabysmo prefilled syringe (PFS) for three leading causes of vision loss
05 juil. 2024 01h00 HE
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F. Hoffmann-La Roche Ltd
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindnessDesigned to simplify administration, Vabysmo PFS...
[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase II/III SKYSCRAPER-06 study in metastatic non-squamous non-small cell lung cancer
04 juil. 2024 01h00 HE
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F. Hoffmann-La Roche Ltd
SKYSCRAPER-06 evaluating tiragolumab plus Tecentriq and chemotherapy did not meet the primary endpoints of progression-free survival at primary analysis and overall survival at first interim...
Roche’s Vabysmo gets CHMP recommendation for third indication retinal vein occlusion (RVO)
28 juin 2024 07h15 HE
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F. Hoffmann-La Roche Ltd
Positive recommendation is based on two Phase III studies. In addition to robust retinal drying with Vabysmo, these data show early and sustained vision improvements, which are non-inferior to...
CHMP recommends EU approval of Roche’s PiaSky for people with PNH, a rare, life-threatening blood condition
28 juin 2024 07h00 HE
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F. Hoffmann-La Roche Ltd
If approved, PiaSky will be the first monthly subcutaneous (SC) treatment for paroxysmal nocturnal haemoglobinuria (PNH) in the EU Additionally, with the option to self-administer, PiaSky may provide...
Roche expands access to cervical cancer screening tools with two new WHO prequalification designations, including HPV self-collection
27 juin 2024 01h00 HE
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F. Hoffmann-La Roche Ltd
The World Health Organization (WHO) has awarded Roche's human papillomavirus (HPV) test prequalification designations for use on the cobas 5800 System and for self-collected samples on the cobas 5800,...
Roche’s OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis
25 juin 2024 01h00 HE
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F. Hoffmann-La Roche Ltd
OCREVUS subcutaneous (SC) injection offers a new, 10-minute administration of OCREVUS with comparable efficacy and safety to intravenous infusion (IV) OCREVUS SC provides an additional treatment...
Roche launches new analytical units for cobas® pro integrated solutions delivering greater efficiency and capacity to laboratories
24 juin 2024 01h00 HE
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F. Hoffmann-La Roche Ltd
The cobas® c 703 and cobas® ISE neo analytical units, deliver higher testing capacity and increased automation helping to improve laboratory workflows and advance patient care.The new cobas c 703...
Roche launches new highly-sensitive test to more easily diagnose patients who may have B-cell lymphoma
20 juin 2024 01h00 HE
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F. Hoffmann-La Roche Ltd
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma...
Roche’s Phase III STARGLO study demonstrates Columvi significantly extends survival in people with relapsed or refractory diffuse large B-cell lymphoma
15 juin 2024 10h00 HE
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F. Hoffmann-La Roche Ltd
The study met its primary endpoint of overall survival with a 41% reduction in the risk of death in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with Columvi...
Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA Emergency Use Authorization
10 juin 2024 01h05 HE
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F. Hoffmann-La Roche Ltd
The test uses highly sensitive PCR technology, requiring only a single nasal-swab sample to provide rapid, accurate qualitative detection and differentiation among four of the most prevalent...