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…
Tag: FDA
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…
FDA Grants Priority Review to Genentech’s Baloxavir Marboxil for the Treatment of Influenza
South San Francisco, CA June 26, 2018 Genentech Press Release — Influenza, or “flu,” represents a serious threat to public health – globally, annual epidemics result in 3 to 5 million cases of severe disease, millions of hospitalizations and up…
Cancer Research Institute Celebrates Sixth Annual Cancer Immunotherapy Month™ in June
South San Francisco, CA June 21, 2018 by Cancer Research Institute 30 days of education and awareness programming for patients, caregivers, and the public about cancer immunotherapy and clinical trials Join in #WearWhite Day on Friday, June 15, our signature…
DA Approves Genentech’s Lucentis (Ranibizumab Injection) 0.3 mg Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy
South San Francisco, CA March 22, 2018 Genentech Press Release First and only prefilled syringe treatment option FDA-approved to treat all forms of diabetic retinopathy in people with or without diabetic macular edema (DME) Diabetic retinopathy is the leading…
FDA Approves Genentech’s Hemlibra (Emicizumab-kxwh) for Hemophilia A with Inhibitors
South San Francisco, CA November 16, 2017 Genentech Press Release First new medicine in nearly 20 years to treat people with hemophilia A with inhibitors HEMLIBRA substantially reduced bleeds in adults and children Only medicine that can be…
FDA Approves Rituxan Hycela (Rituximab and Hyaluronidase Human) for Subcutaneous Injection in Certain Blood Cancers
South San Francisco, CA June 23, 2017 Genentech Press Release Treatment can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous Rituxan — SOUTH SAN FRANCISCO, CA — 2017-06-22 00:00:00 Genentech, a member…
FDA Approves Genentech’s OCREVUS™ (Ocrelizumab) For Relapsing and Primary Progressive Forms of Multiple Sclerosis
South San Francisco, CA March 29, 2017 Genentech Press Release First and only approved disease-modifying therapy for primary progressive form of multiple sclerosis (PPMS) – one of the most disabling forms of multiple sclerosis (MS) An…