Voriconazole is a drug that treats infections caused by fungi.
Vertex Pharmaceuticals Incorporated today announced the U.S. Food and Drug Administration approved KALYDECO® (ivacaftor) to include use in children with cystic fibrosis ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene that is responsive to KALYDECO based on clinical and/or in vitro assay data.
New therapies are improving care, but early diagnosis remains critical in the effective treatment of invasive, a potentially deadly fungal infection, according to new guidelines released by the Infectious Diseases Society of America and published in the journal Clinical Infectious Diseases.
Voriconazole, a prescription drug commonly used to treat fungal infections in lung transplant recipients, significantly increases the risk for skin cancer and even death, according to a new study by UC San Francisco researchers.
Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections.
Astellas today announced that the U.S. Food and Drug Administration has approved its New Drug Application (NDA) for the use of CRESEMBA (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis).
Astellas announced today that the U.S. Food and Drug Administration has granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis.
Astellas reported today that isavuconazole demonstrated successful outcomes in the treatment of mucormycosis according to data from the phase 3 isavuconazole VITAL study being presented at IDWeek on October 10, 2014, in Philadelphia, Pa.
A newly developed antifungal, isavuconazole, is as effective as an existing drug, voriconazole, against invasive mold disease in cancer patients with less adverse effects, according to phase 3 clinical data presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, an infectious disease meeting of the American Society for Microbiology.
Astellas today announced that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive candidiasis, a life-threatening, invasive fungal infection.
Astellas today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients.
Janssen R&D Ireland Ltd announced today that they have entered into a collaboration with ViiV Healthcare to develop and commercialize a new single tablet regimen containing Janssen's Non-Nucleoside Reverse Transcriptase Inhibitor rilpivirine (marketed as EDURANT®) and ViiV's Integrase Inhibitor dolutegravir(marketed as TIVICAY®) as the sole active ingredients for the maintenance treatment of people living with Human Immunodeficiency Virus (HIV).
Astellas reported today that the efficacy and safety data of the isavuconazole invasive aspergillosis study (SECURE) were presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain.
Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.
Astellas Pharma US, Inc., a subsidiary of Astellas Pharma Inc. based in Tokyo, Japan, announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis.
Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.
Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Voriconazole for Oral Suspension, 40 mg/mL, which is the first generic version of Pfizer's VFEND for Oral Suspension.
Spectrum Pharmaceuticals, Inc., a biotechnology company with fully-integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that, through a wholly-owned subsidiary, the company entered into an agreement to acquire Talon Therapeutics, Inc., a biopharmaceutical company based in South San Francisco, California, and expects to complete the acquisition within one day.
Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved its New Drug Application for Nymalize (nimodipine) oral solution.
An estimated 4,837,000 asthmatics with allergic bronchopulmonary aspergillosis (ABPA) could benefit substantially from antifungal treatment, say researchers from the University of Toronto and Manchester University.
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a supplemental new drug application for SUSTIVA (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg.