Media releases Keyword Search Clear 2019 2018 2017 2016 2015 2014 2013 2012 2011 Published on: 19 February 2019 FDA grants Priority Review to Roche’s personalised medicine entrectinib Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and ... more Published on: 19 February 2019 FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in ... more Published on: 6 February 2019 Roche joins the World Federation of Hemophilia Humanitarian Aid Program Roche today announced that it has joined the World Federation of Hemophilia (WFH) Humanitarian Aid Program, a landmark initiative leading the effort to change the lack of access to care and treatment ... more Published on: 5 February 2019 Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Roche today announced completing the submission of a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for Kadcyla® (trastuzumab emtansine) for adjuvant (after ... more Published on: 1 February 2019 CHMP recommends EU approval of Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors Roche today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Hemlibra®(emicizumab) for routine prophylaxis of bleeding episodes in adults ... more Published on: 1 February 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab), in combination with ... more Published on: 31 January 2019 Roche reports very strong results in 2018 Group sales increase 7% at constant exchange rates and in Swiss francs more Published on: 30 January 2019 Roche to discontinue Phase III CREAD 1 and 2 clinical studies of crenezumab in early Alzheimer’s disease (AD) - other company programmes in AD continue - Roche today announced the decision to discontinue CREAD I and CREAD 2 (BN29552 and BN29553) Phase III studies of the investigational anti-beta-amyloid molecule crenezumab in people with early ... more Published on: 17 January 2019 FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq® (atezolizumab) in combination with ... more
Published on: 19 February 2019 FDA grants Priority Review to Roche’s personalised medicine entrectinib Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and ... more
Published on: 19 February 2019 FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in ... more
Published on: 6 February 2019 Roche joins the World Federation of Hemophilia Humanitarian Aid Program Roche today announced that it has joined the World Federation of Hemophilia (WFH) Humanitarian Aid Program, a landmark initiative leading the effort to change the lack of access to care and treatment ... more
Published on: 5 February 2019 Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Roche today announced completing the submission of a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for Kadcyla® (trastuzumab emtansine) for adjuvant (after ... more
Published on: 1 February 2019 CHMP recommends EU approval of Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors Roche today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Hemlibra®(emicizumab) for routine prophylaxis of bleeding episodes in adults ... more
Published on: 1 February 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab), in combination with ... more
Published on: 31 January 2019 Roche reports very strong results in 2018 Group sales increase 7% at constant exchange rates and in Swiss francs more
Published on: 30 January 2019 Roche to discontinue Phase III CREAD 1 and 2 clinical studies of crenezumab in early Alzheimer’s disease (AD) - other company programmes in AD continue - Roche today announced the decision to discontinue CREAD I and CREAD 2 (BN29552 and BN29553) Phase III studies of the investigational anti-beta-amyloid molecule crenezumab in people with early ... more
Published on: 17 January 2019 FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq® (atezolizumab) in combination with ... more