Tag Archives: Approves

FDA Approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma

Print this page KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.– September 17, 2019 — (BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) approved the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available kinase inhibitor discovered by… Read More »

FDA Approves Erleada (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Print this page HORSHAM, Pa., Sept. 17, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).1 Today’s approval follows FDA Priority Review Designation of the supplemental New Drug… Read More »

FDA Approves Myobloc (rimabotulinumtoxinB) Injection for Chronic Sialorrhea

Print this page LOUISVILLE, Ky., Aug. 26, 2019 /PRNewswire/ — US WorldMeds, LLC announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Myobloc (rimabotulinumtoxinB) injection for the treatment of chronic sialorrhea in adults.1 Sialorrhea, or drooling, is defined as an excess spillage of saliva out of… Read More »

FDA Approves Juvéderm Voluma XC For Mid-Face Injection Via Cannula

Print this page DUBLIN, Sept. 3, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) announced today it received U.S. Food and Drug Administration (FDA) approval for the use of Juvéderm Voluma XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE™ cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults… Read More »

FDA Approves Nourianz (istradefylline) as an Add-On Drug to Treat Off Episodes in Adults with Parkinson’s Disease

FDA Approves Nourianz (istradefylline) as an Add-On Drug to Treat Off Episodes in Adults with Parkinson’s Disease Print this page TOKYO–(BUSINESS WIRE)– August 28, 2019 — Kyowa Kirin Co., Ltd., (Kyowa Kirin, TYO: 4151) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Nourianz (istradefylline) for use as adjunctive treatment… Read More »

FDA Approves Xenleta (lefamulin) to Treat Community-Acquired Bacterial Pneumonia (CABP)

FDA Approves Xenleta (lefamulin) to Treat Community-Acquired Bacterial Pneumonia (CABP) Print this page DUBLIN, Ireland, Aug. 19, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the U.S. Food and Drug Administration (FDA) has approved… Read More »