CHMP positive for Mircera to treat paediatric patients with anaemia associated with CKD – Roche

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mircera (methoxypolyethylene glycolepoetin beta). The marketing authorisation holder for this medicinal product is Roche Registration GmbH. The CHMP adopted an extension to an existing indication for use in paediatric patients. For information, the […]

FDA approves Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma – Roche

Roche announced that the FDA has approved Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response […]

Immuno-oncology treatment pre-surgery safe and effective option for localized non-small cell lung cancer

New study data shows that the immuno-oncology drug, atezolizumab (pronounced  a” te zoe liz’ ue mab, marketed as Tecentriq) is a safe and effective treatment for stage IB-IIIB non-small cell lung cancer patients prior to lung cancer surgery, according to a new study led by researchers with The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and […]

Roche presents new data for Evrysdi at World Muscle Society (WMS) 2021 highlighting new advances for people living with rare neuromuscular disorders

Roche announced data from across its growing neuromuscular portfolio at the World Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to six weeks of age and data. At WMS 2021, data […]

Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic NSCLC – Roche

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FDA oncological drugs advisory committee votes in support of Tecentriq in bladder cancer – Genentech/Roche

Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]

CHMP recommends approval of Enspryng for neuromyelitis optica spectrum disorder – Roche

Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]

Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy – Roche

Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]