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Tocilizumab News
FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemra
March 7, 2024 – Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic...
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...
FDA Approves Tofidence (tocilizumab-bavi), a Biosimilar to Actemra
CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) – Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) intravenous...
FDA Approves Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults
South San Francisco, CA – December 21, 2022 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has a...
Genentech’s Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children
South San Francisco, CA – June 24, 2021 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has issued an...
Genentech’s Actemra Becomes the First Biologic Therapy Approved by the FDA for Slowing the Rate of Decline in Pulmonary Function in Adults With Systemic Sclerosis-Associated Interstitial Lung Disease, a Rare, Debilitating Condition
Systemic sclerosis (SSc) is a rare disease that impacts up to 75,000 people in the United States Approximately 80% of SSc patients may be affected by interstitial lung disease (ILD), a progressive...
FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)
South San Francisco, CA – September 13, 2018 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the...
FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis
South San Francisco, CA – May 14, 2018 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the...
FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome
South San Francisco, CA – August 30, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell Arteritis
May 22, 2017 – The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the...
FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis
BASEL, April 30, 2013 – Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis...
FDA Approves Actemra (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA)
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Apr 15, 2011 - Genentech, a member of the Roche Group today announced that the U.S. Food and Drug Administration (FDA) approved Actemra (tocilizumab) for...
FDA Grants Supplemental Approval for Actemra (tocilizumab)
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jan 5, 2011 - Genentech, Inc., a member of the Roche Group, today announced that the United States (U.S.) Food and Drug Administration (FDA) has extended...
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COVID-19, Juvenile Idiopathic Arthritis, Rheumatoid Arthritis