Jul 28th, 2019 - Today, the U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process ...
Jun 26th, 2019 - Dosing See Important Safety Information, including BOXED WARNING.
Mar 6th, 2019 - Filgotinib is a highly selective JAK1 inhibitor, discovered and developed by Galapagos using its target and drug discovery technology platform. In more than 1,600 patient years of rheumatoid arthritis (RA) and Crohn's disease clinical study experience, filgotinib has shown a rapid onset of action, potentially best-in-class efficacy and favorable findings on safety and tolerability. From a regul...
Feb 5th, 2019 - CABLIVI is a von Willebrand factor (vWF)-directed antibody fragment indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Jul 25th, 2018 - bluebird bio, Inc. (Nasdaq: BLUE) today announced that its investigational LentiGlobin™ gene therapy for the treatment of adolescent and adult patients with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype, was granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), for its upcoming marketing author...
Jul 19th, 2018 - TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test
Nov 9th, 2017 - Novartis, a global leader in ophthalmology, announced further positive results from two Phase III studies of brolucizumab versus aflibercept. Results showed non-inferiority in primary endpoint, superiority in key retinal health outcomes, and long-lasting effect in patients with neovascular age-related macular degeneration (nAMD), a leading cause of blindness. The results of the head-to-head tri...
CERDELGA is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
Adempas (riociguat). Visit Adempas-US.com to see full safety and prescribing information, including Boxed Warning. Learn about Adempas and the Aim Patient Support Program.
An in vitro polymerase chain reaction (PCR) assay for the qualitative detection of single nucleotide variants (SNVs)
ABILIFY MAINTENA for the treatment of schizophrenia and the maintenance treatment of bipolar I disorder in adult patients. See full Safety and Prescribing Information, including BOXED WARNING.
ADCIRCA is a trademark of Eli Lilly and Company. http://pi.lilly.com/us/adcirca-ppi.pdf. Please see Important Safety Information and Full Prescribing Information.
The first and only FDA-approved treatment indicated to slow kidney function decline and kidney cyst growth in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
Brentuximab vedotin is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
The myPKFiT software is intended for use by licensed healthcare professionals (HCPs) who are familiar with hemophilia care. The myPKFiT software can be used to generate ADVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16 years of age and older and body ...
AFINITOR® (everolimus) Tablets is contraindicated in patients with ... but alcohol-, hydrogen peroxide-, iodine-, or thyme-containing products should be avoided.
Learn about AFSTYLA, recombinant FVIII therapy that delivers long-lasting bleed protection for patients with hemophilia A. Explore how to sign up your patients for a free 30-day trial.
Aldurazyme® (laronidase) is a prescription only medication indicated for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms.
ARIKAYCE (amikacin liposome inhalation suspension): An FDA-approved medication for the treatment of refractory MAC lung disease. See Prescribing and Safety Information.