South San Francisco, CA December 19, 2023 Press Release FDA Grants Priority Review to Xolair (omalizumab) for Children and Adults With Food Allergies Based on Positive National Institutes of Health Phase III Study Results If approved, Xolair would be the…
Tag: FDA
Genentech’s Alecensa Delivers Unprecedented Phase III Results for People With ALK-Positive Early-Stage Lung Cancer
Voluntary Recall of Frozen Fruit Products
June 27th, 2023 – South San Francisco, CA – from FDA.gov Voluntary Recall of Specific Frozen Fruit Products Due to Possible Contamination by Listeria Monocytogenes Sunrise Growers Inc, a subsidiary of SunOpta Inc, has initiated a voluntary recall for certain…
CDC and FDA Recommend ‘Pause’ in Johnson and Johnson COVID Vaccine
South San Francisco, CA April 13, 2021 from CDC CDC and FDA have recommended a pause in the use of the Johnson & Johnson’s Janssen COVID-19 vaccine in the United States out of an abundance of caution, effective Tuesday, April…
FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder
South San Francisco, CA October 30, 2019 Press Release — Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS) — SOUTH SAN FRANCISCO, CA — October…
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…
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…