Tag Archives: Approves

FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma

PRINCETON, N.J.–(BUSINESS WIRE) October 2, 2020 — Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural… Read More »

FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain

FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain Print this page ATHENS, Ga., Sept. 8, 2020 /PRNewswire/ — Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Qdolo™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults… Read More »

FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of Asthma

Print this page London UK 9 September 2020 — GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to… Read More »

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 »