In the Phase 3 pivotal trial, more than 40 percent of patients receiving STELARA subcutaneous (SC) injections every 8 weeks were in clinical remission at one year and not taking corticosteroids
Single-dose Xofluza is the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from influenza (flu)
32% of Patients Achieved Treatment-Free Remission for at Least Six Months in a Single-Arm Trial
Omega Medical Imaging, manufacturers of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, just announced the Food and Drug Administration 510 (k) clearance of FluoroShield™ with their 2020 Cardiac Flat Panel Detector.
Eli Lilly and Co.'s Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura in adults has received approval from the U.S. Food and Drug Administration (FDA).
XARELTO® provides a new oral option to help prevent venous thromboembolism (VTE) and VTE-related death during hospitalization and post-hospital discharge in acutely ill medical patients at risk for VTE and not at high risk of bleeding
HB Natural Ingredients has received a "Letter of No Objection" for Vitosa stevia sweeteners from the U.S. Food and Drug Administration (FDA), confirming that the agency has "no questions" on the self-affirmed GRAS (generally recognized as safe) status of Vitosa for use as a sweetener in food and beverage products.
The U.S. Food and Drug Administration (FDA) recently granted marketing approval to use Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
First and only single-use, professional CGM system with blinded or unblinded mode
Novartis today announced that the U.S. Food and Drug Administration (FDA) approved BEOVU® (brolucizumab-dbll) injection, also known as RTH258, for the treatment of wet age-related macular degeneration (AMD)
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Will allow initiation of Early Feasibility Study in Head and Neck Cancer
The U.S. Food and Drug Administration approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
Milestone approval establishes AI-powered solution as the foundation for future disease-specific predictive management tools from Biofourmis
Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the rate of discontinuation due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.
Novartis recently reported results from the MONALEESA-3 trial, the largest to evaluate a CDK4/6 inhibitor plus fulvestrant as initial therapy in postmenopausal women (N=726), which showed that CDK4/6 inhibitor Kisqali (ribociclib) demonstrated statistically significant improvement in overall survival (OS).
Eli Lilly and Company recently announced that results of the LIBRETTO-001 clinical trial intended to support the registration of oral selpercatinib monotherapy, also known as LOXO-292, were presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain.
Epica International, Inc. (Epica), received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SeeFactorCT3™ Imaging Platform. SeeFactorCT3™ consists of 3 integrated imaging systems: CT, Fluoroscopy and Digital Radiography; a detachable patient table/chair, and sterile drape for interventional procedures. FDA clearance allows Epica to market these products in the United States.