South San Francisco, CA April 29, 2019 Genentech Press Release Risdiplam data from Part 1 of pivotal FIREFISH study show infants with Type 1 spinal muscular atrophy achieve key motor milestones and improved survival after one year of treatment New…
Tag: Genentech
Letter to the Editor: A Word to YIMBY’s About the Suburbs and Those That Live Here
South San Francisco, CA April 27, 2019 by Corey David, SSF Resident Dear Editor and neighbors, It has been brought to my attention that there has been dismay expressed in both ESC and Nextdoor that those of us demanding responsible…
FDA Grants Genentech’s New Med for Breast Cancer
South San Francisco, CA March 8, 2019 Genentech Press Release FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer — This Tecentriq combination is the first cancer immunotherapy regimen approved for breast…
FDA Accepts Genentech’s Supplemental New Drug Application for Xofluza (baloxavir marboxil)
South San Francisco, CA March 6, 2019 Genentech Press Release FDA Accepts Genentech’s Supplemental New Drug Application for Xofluza (baloxavir marboxil) for the Treatment of Influenza in People at High Risk of Complications — XOFLUZA would be the first antiviral…
FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib
South San Francisco, CA February 20, 2019 Genentech Press Release Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs)…
Genentech Submits Supplemental Biologics License Application to FDA; Breast Cancer
South San Francisco, CA February 8, 2019 Genentech Press Release Genentech Submits Supplemental Biologics License Application to FDA For Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment — Application is being…
Genentech Announces FDA Approval of XOFLUZA (Baloxavir Marboxil) for Influenza
South San Francisco, CA October 24, 2018 Genentech Press Release — First and only single-dose oral medicine approved to treat the flu — — XOFLUZA significantly reduced the duration of flu symptoms compared to placebo — — First novel proposed…
Genentech’s Latest Effort to Combat Breast Cancer
South San Francisco, CA October 16, 2018 Press Release Genentech’s Kadcyla Reduced the Risk of Disease Recurring in People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment — Phase III KATHERINE study shows Kadcyla® significantly improved invasive…
FDA Approves Genentech’s Hemlibra
South San Francisco, CA October 4, 2018 Press Release FDA Approves Genentech’s Hemlibra (Emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis based on an intra-patient comparison Only…
FDA Approves Genentech’s Xolair (Omalizumab) Prefilled Syringe Formulation
South San Francisco, CA September 29, 2018 Press Release FDA Approves Genentech’s Xolair (Omalizumab) Prefilled Syringe Formulation — Xolair, the only biologic approved for both allergic asthma and chronic idiopathic urticaria indications, is now also approved in a prefilled syringe…