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Chemotherapy News

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U.S. FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta

Posted 6 Jun 2018 by Drugs.com

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018 /PRNewswire/ – Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of ...

FDA Approves Cinvanti (aprepitant) Injectable Emulsion for the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting (CINV)

Posted 14 Nov 2017 by Drugs.com

SAN DIEGO--(BUSINESS WIRE)--Nov. 9, 2017-- Heron Therapeutics, Inc. (Nasdaq: HRTX) (the Company or Heron), a commercial-stage biotechnology company focused on developing novel, best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved Cinvanti (aprepitant) injectable emulsion, for intravenous ...

Tesaro Announces U.S. FDA Approval of Varubi IV for Delayed Nausea and Vomiting Associated With Cancer Chemotherapy

Posted 30 Oct 2017 by Drugs.com

WALTHAM, Mass., Oct. 25, 2017 (GLOBE NEWSWIRE) – Tesaro, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Varubi (rolapitant) IV in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer ...

Insys Therapeutics Announces FDA Approval of Syndros (dronabinol) Oral Solution

Posted 5 Jul 2016 by Drugs.com

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, Syndros, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC"). Syndros is approved for ...

FDA Approves Vistogard (uridine triacetate) for Emergency Treatment for Overdose of Certain Types of Chemotherapy

Posted 12 Dec 2015 by Drugs.com

December 11, 2015 – The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments. “Treating cancer requires not only selecting w ...

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