Roche Gazyva application accepted by USFDA for lupus nephritis Ruchika Sharma5 March 2025 1:45 PM ISTGazyva/Gazyvaro is an anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a CRR benefit in lupus nephritis.
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu Ruchika Sharma1 Feb 2025 12:30 PM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY anti-HER2/neu (4B5)...
Roche names Wafaa Mamilli as Chief Digital Technology Officer Ruchika Sharma31 Jan 2025 1:30 PM ISTBasel: Roche has announced that Wafaa Mamilli will join the company as Chief Digital Technology Officer (CDTO), reporting to Group CEO, Thomas...
Roche receives USFDA clearance with CLIA waiver for cobas liat sexually transmitted infection multiplex assay panels Ruchika Sharma26 Jan 2025 10:30 AM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement...
Roche gets USFDA clearance for highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma Ruchika Sharma14 Jan 2025 4:06 PM ISTBasel: Roche has announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its...
Roche has no plans for job cuts and business is healthy: CEO Ruchika Sharma31 Dec 2024 4:48 PM ISTPharmaceutical giant Roche has no plans for workforce reductions and the company's business is healthy, CEO Thomas Schinecker was...
Roche Vabysmo prefilled syringe approved in EU for three retinal conditions that can cause blindness Ruchika Sharma15 Dec 2024 1:15 PM ISTBasel: Roche has announced that the European Medicines Agency has approved Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use...
USFDA accepts application for Roche Columvi combination for relapsed or refractory diffuse large B cell lymphoma Ruchika Sharma5 Dec 2024 11:30 AM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License...
Roche to acquire Poseida Therapeutics for USD 1.5 billion Ruchika Sharma1 Dec 2024 10:45 AM ISTBasel: Roche has announced that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc., a public clinical-stage...
Roche launches cobas Respiratory flex test to detect up to 12 most common respiratory viruses Ruchika Sharma24 Sept 2024 3:38 PM ISTBasel: Roche announced today the launch of the cobas Respiratory flex test, the first to use Roche's novel and proprietary TAGS...
Roche PiaSky approved in EU as monthly subcutaneous treatment for paroxysmal nocturnal haemoglobinuria Ruchika Sharma28 Aug 2024 10:00 AM ISTBasel: Roche has announced that the European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the...
Roche receives CE Mark for AI-enabled continuous glucose monitoring solution for diabetes patients Ruchika Sharma10 July 2024 12:30 PM ISTBasel: Roche has announced that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This paves...
