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The U.S. Food and Drug Administration approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher.
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The U.S. Food and Drug Administration authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).
Joint FDA/ASH Led Initiative Highlights Importance of Using Patient Reported Outcomes and Biomarkers in Clinical Trials to Advance SCD Therapies
Results from Phase 1b/2 CARTITUDE-1 to premiere in oral presentation at ASH 2019 (Abstract #577)
Liveyon Labs Inc. and Liveyon LLC warned that their stem cell products lack required FDA approval and represent a potential risk to the public health
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The U.S. Food and Drug Administration today announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device.
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The U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.
Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
Application is being reviewed under the FDA's Real-Time Oncology Review pilot program
TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma.
Phase 2 clinical trial of neflamapimod in patients with mild-to-moderate DLB currently enrolling patients in the U.S. and the Netherlands
Public health and safety is the highest priority at the U.S. Food and Drug Administration.
This is the 7th FDA 510(k) clearance for BlueStar, which was initially cleared for adults with type 2 diabetes
Today, the U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology.
Will be available in fall 2020, in time for the 2020-2021 flu season
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery.
Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, today announced that following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration (FDA), there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer.