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 …
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10 August
FDA Approves Heron’s Sustol Extended-Release Injection for the Prevention of CINV

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Heron Therapeutics, Inc. (NASDAQ:HRTX), today announced that the U.S. Food and Drug Administration (FDA) has approved SUSTOL® (granisetron) extended-release injection. SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with …
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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 …
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29 May
Heron’s Investigational CINV Drug Succeeds in Late-Stage Study

Heron Therapeutics said that its experimental drug for treating chemotherapy-induced nausea and vomiting (CINV) met its primary endpoint in a late-stage study. Following repeated delays, the positive news sent the company’s shares up more than 40 percent in extended trading. Heron announced top-line results from its Phase III MAGIC study, …
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