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Author: Admin | 2025-04-28
2 to less than 18 years old is not FDA approved and remains under Emergency Use Authorization (EUA).Development timeline for ActemraDateArticleDec 21, 2022Approval FDA Approves Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized AdultsJun 24, 2021Genentech’s Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and ChildrenMar 4, 2021Approval 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 ConditionNov 26, 2018Approval FDA Approves The ACTpen for Actemra, A Single-Dose, Prefilled AutoinjectorSep 13, 2018Approval FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)May 14, 2018Approval FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic ArthritisAug 31, 2017Approval FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release SyndromeMay 22, 2017Approval FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell ArteritisOct 22, 2013Approval Genentech Gains FDA Approval for New Subcutaneous Formulation of Actemra for use in Adult Patients Living with Moderately to Severely Active Rheumatoid ArthritisApr 30, 2013Approval FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic ArthritisApr 17, 2011Approval FDA Approves Actemra (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA)Jan 5, 2011Approval FDA Grants Supplemental Approval for Actemra (tocilizumab)Jan 11, 2010Approval FDA Approves Actemra for the Treatment of Moderately to Severely Active Rheumatoid ArthritisDec 4, 2008Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab)Sep
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