Tag Archives: Approves

FDA Approves Xeglyze (abametapir) Lotion for the Treatment of Head Lice

FDA Approves Xeglyze (abametapir) Lotion for the Treatment of Head Lice Print this page HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE) July 27, 2020 –Dr. Reddy’s Laboratories Ltd. today announced approval of Xeglyze (abametapir) lotion, 0.74%, a 505(b)(1) NDA by the U.S. Food and Drug Administration. The approval triggers the contractual pre-commercialization milestone of $ 20… Read More »

FDA Approves Second Biomarker-Based Indication for Merck’s Keytruda (pembrolizumab), Regardless of Tumor Type

Print this page KENILWORTH, N.J.–(BUSINESS WIRE) June 17, 2020 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high… Read More »

FDA Approves Merck’s Recarbrio (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

Print this page KENILWORTH, N.J.–(BUSINESS WIRE) June 5, 2020 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Recarbrio™ (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age… Read More »

FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy

Print this page PRINCETON, N.J.–(BUSINESS WIRE) June 10, 2020 Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.1 This application was granted… Read More »

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Pomalyst (pomalidomide) for AIDS-Related and HIV-Negative Kaposi Sarcoma

Print this page PRINCETON, N.J.–(BUSINESS WIRE)–May 15, 2020 — Bristol Myers Squibb (NYSE: BMY) today announced that Pomalyst ® (pomalidomide) was approved by the U.S. Food and Drug Administration (FDA) for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are… Read More »

FDA Approves Trodelvy (sacituzumab govitecan-hziy) for Previously-Treated Metastatic Triple Negative Breast Cancer

FDA Approves Trodelvy (sacituzumab govitecan-hziy) for Previously-Treated Metastatic Triple Negative Breast Cancer Print this page Morris Plains, N.J., April 22, 2020 — Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy™ (sacituzumab govitecan-hziy) for the treatment… Read More »

FDA Approves Koselugo (selumetinib) for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

FDA Approves Koselugo (selumetinib) for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas Print this page 13 April 2020 — AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved the kinase inhibitor Koselugo… Read More »