Tag Archives: CINV

January, 2017

  • 13 January

    FDA Denies Approval of Tesaro’s NDA for its Rolapitant IV

    WALTHAM, Mass., Jan. 11, 2017 (GLOBE NEWSWIRE) — TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the rolapitant IV New Drug Application (NDA) for the prevention of delayed nausea and vomiting associated with …

August, 2016

July, 2016

  • 5 July

    FDA Approves Insys’ Cannabis-Based Drug for Cancer, AIDS-Related Weight Loss

    PHOENIX, July 05, 2016 (GLOBE NEWSWIRE) — Insys Therapeutics, Inc. (“Insys” or “the Company”) (NASDAQ:INSY) today announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, SyndrosTM, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (“THC”).  Syndros is …

May, 2015