Tag Archives: approves

FDA Approves Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for Cystic Fibrosis Patients Ages 12 and Older Who Have at Least One F508del Mutation

FDA Approves Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for Cystic Fibrosis Patients Ages 12 and Older Who Have at Least One F508del Mutation Print this page BOSTON–(BUSINESS WIRE)–Oct. 21, 2019– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF)… Read More »

FDA Approves Beovu (brolucizumab-dbll) for the Treatment of Wet Age-Related Macular Degeneration (AMD)

FDA Approves Beovu (brolucizumab-dbll) for the Treatment of Wet Age-Related Macular Degeneration (AMD) Print this page EAST HANOVER, N.J., Oct. 8, 2019 /PRNewswire/ — Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Beovu (brolucizumab-dbll) injection, also known as RTH258, for the treatment of wet age-related macular degeneration (AMD)1. Beovu is the… 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 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 »