Tag Archives: eisai

September, 2016

May, 2016

  • 16 May

    FDA Expands Approval of Eisai’s Lenvima in Kidney Cancer

    WOODCLIFF LAKE, N.J., May 13, 2016 /PRNewswire/ — Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) approved LENVIMA® (lenvatinib), the company’s multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an …

  • 2 May

    FDA Approves Oral Suspension Formulation of Eisai’s Fycompa

    WOODCLIFF LAKE, N.J., May 2, 2016 /PRNewswire/ — Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved FYCOMPA® (perampanel) CIII Oral Suspension as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in …

February, 2016

January, 2016

  • 19 January

    Eisai’s Kidney Cancer Drug Receives Priority Review from the FDA

    WOODCLIFF LAKE, N.J., Jan. 17, 2016 /PRNewswire/ — Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for lenvatinib for the potential treatment of patients with unresectable advanced or metastatic renal cell carcinoma (RCC) in combination with …

December, 2015

  • 7 December

    Morphotek Announces Early-Stage Results from its Rheumatoid Arthritis Study

    EXTON, Pa., Dec. 7, 2015 /PRNewswire/ — Morphotek®, Inc., a subsidiary of Eisai Inc., announced today results from Study MORAb-022-001, a single-dose, dose-ascending, placebo-controlled, Phase 1 trial evaluating the safety and tolerability of its investigational, anti-GM-CSF, monoclonal antibody, MORAb-022 in healthy subjects (n=26) and mild-to-moderate Rheumatoid Arthritis (RA) patients (n=25). In this …

November, 2015

March, 2015

February, 2015

  • 13 February

    FDA Expands Approval of Eisai’s Banzel for Pediatric Patients Ages 1-4

    Eisai Inc. announced that US health regulators expanded approval of Banzel (rufinamide) as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients. The company said that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Banzel for treatment of …

  • 13 February

    Eisai’s Thyroid Cancer Drug Receives Early FDA Approval

    The US Food and Drug Administration (FDA) has granted an early approval to Eisai’s drug for the most common form of thyroid cancer. The agency announced that it has approved the Japanese drugmaker’s Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive …