Amgen asks FDA to consider new uses for Xgeva
Thousand Oaks-based biotech giant Amgen announced June 19 that the U.S. Food and Drug Administration has accepted a supplemental application for Xgeva (denosumab) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. “Multiple Read More →
Europeans OK Amgen’s Kyprolis for multiple myeloma treatment
European regulators approved Amgen’s potential blockbuster drug Kyprolis on July 4 as a treatment for multiple myeloma. The European Commission approved a treatment of Kyprolis and dexamethasone in patients who’ve received at least one previous multiple myeloma treatment. In November, the commission approved a Kyprolis treatment using lenalidomide and dexamethasone for patients who’ve received at Read More →
Amgen drug Kyprolis gets another FDA approval
Amgen scored another victory for its breakthrough multiple myeloma drug on Jan. 21. The Thousand Oaks-based biotech giant hit it big when the Food and Drug Administration approved revolutionary multiple myeloma drug Kyprolis for treatments with Kyprolis in combination with another drug. The FDA also approved Kyprolis to treat patients on its own for those Read More →
Amgen cancer drug Kyprolis to get expedited review from FDA
An experimental multiple myeloma treatment using Amgen’s Kyprolis will get an expedited review from the U.S. Food and Drug Administration. The FDA said it will use an expedited review process to review a multiple-myeloma treatment using Kyprolis and the genric drug dexamethasone. On July 23, Amgen submitted additional data to the FDA which compared this Read More →
Amgen’s gamble on new cancer drug may pay off
This article is only available to Business Times subscribers Subscribers: LOG IN or REGISTER for complete digital access. Not a Subscriber? SUBSCRIBE for full access to our weekly newspaper, online edition and Book of Lists. Check the STATUS of your Subscription Account.
