Tag Archives: Actemra

November, 2018

28 November
FDA Approves ACTPen for Genentech’s Actemra, a Single-Dose, Prefilled Autoinjector for Treatment of RA, GCA and Two Forms of Juvenile Arthritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–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 ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab) as an additional formulation for adult patients with moderate to severe active …
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13 September
FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–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 subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age …
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14 May
FDA Approves Subcutaneous Formulation of Actemra for Use in Active Polyarticular Juvenile Idiopathic Arthritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–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 subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age …
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1 September
Genentech’s Actemra Receives FDA Approval 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 Actemra®(tocilizumab) intravenous injection for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release …
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27 July
Genentech’s Actemra Demonstrates Positive Results in Phase 3 Study in Patients with Giant Cell Arteritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from the Phase III GiACTA study, which evaluated Actemra® (tocilizumab) in adult patients with GCA, were published in the July 27, 2017 issue of the New England Journal of Medicine. The primary …
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23 May
FDA Approves Genentech’s Actemra for Treatment of Giant Cell Arteritis

South San Francisco, CA — May 22, 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 Actemra® (tocilizumab) subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition. Actemra is the …
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24 January
FDA Grants Priority Review to Genentech’s Actemra for Giant Cell Arteritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Supplemental Biologics License Application (sBLA) for Actemra® (tocilizumab) for the treatment of GCA, a chronic, potentially life-threatening autoimmune condition. The …
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5 October
FDA Grants Breakthrough Therapy Status to Actemra for Giant Cell Arteritis

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Actemra®(tocilizumab) for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. The disease is caused by inflammation of large and …
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10 June
FDA Grants Breakthrough Therapy Designation to Actemra for Systemic Sclerosis

US health regulators have granted Breakthrough Therapy designation to Genentech’s Actemra (tocilizumab) for systemic sclerosis. Genentech, a member of the Roche Group, said that the US Food and Drug Administration (FDA) has granted Breakthrough status to Actemra for systemic sclerosis, also known as scleroderma, a rare, chronic disorder characterized by …
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