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Results For "Roche"

220 News Found

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


WHO endorses Roche’s dual-stain cytology testing in its cervical cancer prevention guidelines
Clinical Trials | September 23, 2024

WHO endorses Roche’s dual-stain cytology testing in its cervical cancer prevention guidelines

Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results


Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis
Drug Approval | September 19, 2024

Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis

This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally


FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy
Drug Approval | September 16, 2024

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous


Roche’s fenebrutinib demonstrated near-complete suppression of disease activity and disability progression
Clinical Trials | September 04, 2024

Roche’s fenebrutinib demonstrated near-complete suppression of disease activity and disability progression

New Phase II data show vast majority of patients experiencing no relapses or disability progression


Roche’s PiaSky approved in the EU for treatment of people with PNH
Drug Approval | September 03, 2024

Roche’s PiaSky approved in the EU for treatment of people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH
News | August 27, 2024

Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


Roche responds to WHO’s declaration of health emergency due to mpox outbreak
Healthcare | August 23, 2024

Roche responds to WHO’s declaration of health emergency due to mpox outbreak

Roche confirms that its cobas MPXV test, as well as the LightMix research use only kits, detect the latest mpox virus variants


Roche closes acquisition of LumiraDx’s Point of Care technology
News | August 05, 2024

Roche closes acquisition of LumiraDx’s Point of Care technology

The acquisition of LumiraDx’s Point of Care technology received all required antitrust and regulatory clearances


European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
Drug Approval | August 03, 2024

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept