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Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis)

Written by | 13 Dec 2025

Roche announced  that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted FDA 510(k) clearance and Clinical Laboratory Improvement… read more.

Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test to diagnose dengue

Written by | 20 Nov 2025

Roche announced that it has received CE mark for its Elecsys Dengue Ag test – a high-throughput, fully automated immunoassay to be used as an aid in the… read more.

Roche to showcase new data across its haematology portfolio highlighting progress in haemophilia, lymphoma and myeloma at ASH 2025

Written by | 15 Nov 2025

Roche announced that it will showcase 46 abstracts, including 12 oral presentations, from its industry-leading haematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition,… read more.

Genentech to highlight innovation in hemophilia, lymphoma and myeloma at ASH 2025

Written by | 10 Nov 2025

Genentech, a member of the Roche Group announced  that it will showcase 46 abstracts, including 12 oral presentations, from its industry-leading hematology portfolio at the 67th American Society… read more.

FDA approves Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis – Roche

Written by | 1 Nov 2025

Roche announced  that the FDA  has approved Gazyva/Gazyvaro (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as… read more.

Roche to present new oncology data across more than 10 cancer types at ESMO Congress 2025

Written by | 13 Oct 2025

Roche announced that it will present more than 30 abstracts across more than 10 cancer types at the European Society for Medical Oncology (ESMO) Congress 2025, held 17-21… read more.

CHMP recommends EU approval of Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma – Roche

Written by | 8 Aug 2025

Roche announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for… read more.

CHMP positive recommendation for Xofluza (baloxavir marboxil) for infant patients in the EU for the treatment of uncomplicated influenza – Roche

Written by | 5 Aug 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Xofluza. The marketing authorisation… read more.

Roche showcases Trontinemab advances and blood test breakthroughs at AAIC 2025

Written by | 28 Jul 2025

Roche announced that new data from its Alzheimer’s development portfolio is being presented at the Alzheimer’s Association International Conference (AAIC) in Toronto, Canada (July 27-30). These data exemplify… read more.

Roche receives CE Mark for its Chest Pain Triage algorithm to enhance detection of acute coronary syndrome

Written by | 17 Jul 2025

Roche announced the introduction of its innovative Chest Pain Triage algorithm as part of the navify  Algorithm Suite. This groundbreaking algorithm is designed to more quickly and accurately… read more.

FDA approves Susvimo (ranibizumab injection) for diabetic retinopathy – Roche

Written by | 6 Jul 2025

Roche announced that the FDA has approved Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million… read more.

CHMP recommends EU approval of Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer – Roche

Written by | 2 Jul 2025

Roche announced today that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Itovebi (inavolisib), in combination with palbociclib (Ibrance) and… read more.

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