Genentech, a member of the Roche Group received FDA approval for 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications. The new Xolair PFS formulation is expected to be available by the end of this year for the…
FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis
Genentech, a member of the Roche Group, received FDA approval of the subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older. Actemra can be given alone or in combination with methotrexate (MTX) in patients with SJIA. In 2011, FDA approved the…
FDA Grants Breakthrough Therapy Designation For Food Allergy Med
FDA Advances Genentech’s Zelboraf to Treat Rare Blood Disease
Roche Group Unit Receives Breakthrough Therapy Designation for Rituxan
FDA Approves Tecentriq for People With Specific Type of Cancer
SOUTH SAN FRANCISCO, Calif. – Genentech, a member of the Roche Group has announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if…