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...
European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer
10 juin 2024 01h00 HE
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F. Hoffmann-La Roche Ltd
European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer Alecensa reduced the risk of disease...
Five-year data for Roche’s Evrysdi show the majority of treated children with a severe form of spinal muscular atrophy (SMA) achieved or maintained the ability to sit, stand or walk
07 juin 2024 10h40 HE
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F. Hoffmann-La Roche Ltd
After five years of treatment, 91% of children were alive — without treatment, children with Type 1 SMA would not be expected to live past two years of age96% of Evrysdi-treated children could...