Tag Archives: approves

FDA Approves Nubeqa (darolutamide) for Men with Non-Metastatic Castration-Resistant Prostate Cancer

FDA Approves Nubeqa (darolutamide) for Men with Non-Metastatic Castration-Resistant Prostate Cancer Print this page WHIPPANY, N.J., July 30, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1 The FDA approval is based on the Phase III ARAMIS trial evaluating… Read More »

FDA Approves Otezla (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease

Print this page SUMMIT, N.J.–(BUSINESS WIRE) July 19, 2019 — Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Otezla (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. Otezla, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the… Read More »

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 »