Showing posts with the label Roche

Roche renews partnership with Sysmex to deliver haematology testing solutions

IndustryPRwire -- Roche  announced that, on 14 December, 2020, it signed a Global Business Partnership Agreement* (GBP) with Sysmex. Under this new framework, the parties renewed their commitment to …

Roche launches two digital pathology image analysis algorithms for precision patient diagnosis in breast cancer

IndustryPRwire - Roche announced the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis for breast cancer to help determine…

FDA approves Roche’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis

IndustryPRwire - Roche announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS® (ocrelizumab), dosed twice-yearly for those living with r…

Roche launches cobas PIK3CA Mutation Test for patients with advanced or metastatic breast cancer in countries accepting the CE mark

IndustryPRwire - Roche announced the launch of the cobas® PIK3CA Mutation Test for patients with advanced or metastatic breast cancer. Previously only available as research use only (RUO), this in v…

Roche partners with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials

IndustryPRwire - Roche announced a partnership with Moderna to utilise the Elecsys® Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. This will facilitate the quantita…

Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies

IndustryPRwire - Roche announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The serology (blood…

FDA approves Xolair® (omalizumab) for adults with nasal polyps

IndustryPRwire - Roche announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on…

Genentech Announces FDA Approval of Gavreto (pralsetinib) for People With Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

IndustryPRwire -- Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adult and pediatric patie…

Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person

IndustryPRwire -- Roche announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) as a treatment to prevent…

European Commission approves Roche’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer

Roche announced that the European Commission has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepat…

Roche’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer

Roche announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unre…

Roche announces collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients

Roche and Atea Pharmaceuticals, Inc. announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute AT-527, Atea’s investigational oral direct-acti…

Roche announces full FDA approval for Venclexta combinations for acute myeloid leukaemia

Roche announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for …

Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients

Roche announced today that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. The test is…
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