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Versius surgical robot begins first gynaecological procedures in NHS hospital – CMR Surgical

Written by | 15 May 2021

CMR Surgical (CMR) – a global surgical robotics business – announced the expanded use of its next-generation surgical robotic system Versius in Europe. For the first time, Versius… read more.

Merck Inc. at Organon investor day outlines the vision and plans for the new company

Written by | 14 May 2021

Merck Inc., hosted on 3 May an Organon management investor day meeting, to detail across women’s health, biosimilars and established brands.The new company will be launched on 3… read more.

European Commission approves Benlysta for adult patients with active lupus nephritis – GSK

Written by | 13 May 2021

GlaxoSmithKline plc announced the European Commission has approved the expanded use of intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult… read more.

Pfizer and BioNTech receive Health Canada authorization of COVID-19 vaccine in adolescents

Written by | 12 May 2021

Pfizer Canada ULC and BioNTech SE announced that Health Canada has expanded the Interim Order authorization for their COVID-19 vaccine to include individuals 12 to 15 years of… read more.

New analysis of Uplizna for neuromyelitis optica spectrum disorder is published in Neurology Neuroimmunology & Neuroinflammation – Horizon Therapeutics

Written by | 11 May 2021

Horizon Therapeutics plc announced the publication of a new analysis of the pivotal Phase II/III N-MOmentum trial for Uplizna (inebilizumab-cdon), assessing the potential for reduced risk of worsening… read more.

Use of the AstraZeneca COVID-19 (AZD1222) vaccine: updated Joint Committee on Vaccination and Immunisation (UK) statement

Written by | 10 May 2021

Department of Health & Social Care (UK) Statement made on 7 May 2021:There have been reports of extremely rare adverse events of concurrent thrombosis (blood clots) and thrombocytopenia… read more.

Health Canada approves Darzalex + bortezomib + cyclophosphamide + dexamethasone to treat light chain amyloidosis – Janssen Biotech

Written by | 9 May 2021

Health Canada has approved daratumumab injection (Darzalex SC), a subcutaneous formulation of daratumumab (Darzalex), for use in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd; VCd) in the treatment… read more.

FDA approves Zylonta for large B-cell lymphoma – ADC Therapeutics

Written by | 8 May 2021

ADC Therapeutics announced that the FDA has approved Zylonta (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or… read more.

FDA issues complete response letter for Tysabri supplemental filing in SC form for multiple sclerosis – Biogen

Written by | 7 May 2021

Biogen Inc. announced that it has received a Complete Response Letter from the FDA for its supplemental Biologic License Application (sBLA) for a new subcutaneous route of administration… read more.

European Commission approves Epidyolex for the treatment of seizures associated with tuberous sclerosis complex – GW Pharma/Jazz Pharma

Written by | 6 May 2021

GW Pharmaceuticals plc announced that the European Commission (EC) has approved the Type II variation application for Epidyolex (cannabidiol) as an adjunctive treatment of seizures associated with TSC,… read more.

A single dose of either the Pfizer/BioNTech or the AstraZeneca/Oxford COVID-19 vaccines reduced household transmission by up to a half

Written by | 5 May 2021

A single dose of either the Pfizer/BioNTech or the AstraZeneca/Oxford COVID-19 vaccines reduced household transmission by up to a half, according to new research by Public Health England… read more.

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

Written by | 4 May 2021

Genentech/Roche announced the FDA Oncologic Drugs Advisory Committee voted 10 to 1 in favor of maintaining accelerated approval of Tecentriq (atezolizumab) for the treatment of adults with locally… read more.

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