BioSpace News Archive

FDA

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 (PFS) formulation

September 28, 2018
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8 min read
FDA

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

First drug granted approval under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs, instituted to spur development of antibiotics for unmet medical needs

September 28, 2018
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4 min read
FDA

FDA Grants De Novo Designation for Adaptive Biotechnologies’ clonoSEQ Assay to Detect and Monitor Minimal Residual Disease (MRD) in Patients with Multiple Myeloma and Acute Lymphoblastic Leukemia

clonoSEQ is a first-in-class NGS assay and the first and only FDA-cleared MRD assay for any lymphoid cancer

September 28, 2018
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9 min read