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FDA Approves Merck’s Keytruda in Combination with Chemotherapy for First-Line Treatment of Metastatic Squamous NSCLC

KENILWORTH, N.J.–(BUSINESS WIRE)–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, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell …

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FDA Grants Breakthrough Therapy Designation for UroGen Pharma’s UGN-101 for the Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer

RA’ANANA, Israel & NEW YORK–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to the Company’s lead product …

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Aptatek Receives FDA Breakthrough Device Designation for a Home-Based Test System that Enables Patients to Monitor Blood levels of Phenylalanine in Real Time

PRINCETON, N.J.–(BUSINESS WIRE)–Aptatek BioSciences, Inc. a pioneer in home-based monitoring of small molecule biomarkers, announced that their PKU test system for real time monitoring of blood phenylalanine levels by phenylketonuria (PKU) patients has received Breakthrough Device designation from the FDA Center for Devices and Radiological Health (CDRH). The Aptatek test …

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FDA Grants Priority Review to Taiho Oncology’s sNDA for Lonsurf for Treatment of GEJ Adenocarcinoma

PRINCETON, N.J., October 25, 2018 – Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted and granted priority review for the supplemental New Drug Application (sNDA) for LONSURF® (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including …

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FDA Grants Priority Review to Incyte’s Ruxolitinib for Treatment of Patients with Acute Graft-Versus-Host Disease

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host-disease (GVHD) who have had an inadequate response to corticosteroids. The FDA grants Priority Review …

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FDA Grants Orphan Drug Designation to Omeros’ OMS721 for Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ:OMER) today announced that OMS721 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin …

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FDA Approves Spectrum Pharmaceuticals’ Khapzory for Injection for Three Indications

HENDERSON, Nev.–(BUSINESS WIRE)–Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved KHAPZORY (levoleucovorin) for injection, a folate analog for three indications: • Rescue …

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FDA Approves Label Update for Genentech’s Rituxan for Treatment of Two Rare Forms of Vasculitis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved an update to the Rituxan® (rituximab) label to include information on follow up treatment of adult patients with Granulomatosis with Polyangiitis (GPA) and …

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FDA Approves Pfizer’s Talazoparib for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer

On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for …

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FDA Grants Priority Review to AbbVie’s sNDA for Imbruvica in Combination with Gazyva for Previously Untreated Chronic Lymphocytic Leukemia

NORTH CHICAGO, Ill., Oct. 17, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or …

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