Roche to reintroduce Susvimo in the US for people with neovascular age-related macular degeneration (nAMD)
08 juil. 2024 11h45 HE
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F. Hoffmann-La Roche Ltd
The FDA has approved updates to Susvimo, which will be available to US retina specialists and patients with nAMD in the coming weeksSusvimo offers the first alternative to regular eye injections that...
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...