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 Ruzurgi (amifampridine) for Children with Lambert-Eaton Myasthenic Syndrome

FDA Approves Ruzurgi (amifampridine) for Children with Lambert-Eaton Myasthenic Syndrome Print this page May 06, 2019 — The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years to less than 17 years of age. This is the first FDA approval of a… Read More »