Tag Archives: Approves

FDA Approves Kanjinti (trastuzumab-anns), a Biosimilar to Herceptin

FDA Approves Kanjinti (trastuzumab-anns), a Biosimilar to Herceptin Print this page THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Kanjinti (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant… Read More »

FDA Approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for Type 2 Diabetes

FDA Approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for Type 2 Diabetes Print this page  3 May 2019 — The US Food and Drug Administration (FDA) has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with… Read More »

FDA Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel (etanercept)

News New Drugs FDA Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel (etanercept) Print this page April 26, 2019 The FDA has approved Eticovo (etanercept-ykro), a biosimilar to U.S.-licensed Enbrel (etanercept). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product,… Read More »