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The U.S. Food and Drug Administration approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media).
XCOPRI is approved for the treatment of partial-onset seizures in adult patients
Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices
The future of imaging is here—and FDA cleared.
Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients
VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability
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Medicines360, a global nonprofit organization with a mission to expand women's access to quality medicines, and Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360's Supplemental New Drug Application (sNDA) to extend the duration of use of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to six years.
Approval Marks 11th BOTOX® Therapeutic Indication and Comes 30 Years After the First Indications Were Approved
The highly anticipated approval of Beovu® (brolucizumab) may reduce the frequency of intravitreal injections for wet age-related macular degeneration patients following clinical trials at Wolfe Eye Clinic
The U.S. Food and Drug Administration (FDA) has approved AMZEEQTM (minocycline) topical foam, 4 percent. Manufactured by Foamix Pharmaceuticals Ltd., AMZEEQ, formerly known as FMX101, is the first topical minocycline to be approved by the FDA for any condition.
Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes.1 Fiasp®, a rapid-acting insulin, was approved by the FDA in 2017 for use by intravenous infusion under supervision by a healthcare professional or by subcutaneous multiple daily injection (MDI) in adults with diabetes.
The U.S. Food and Drug Administration's (FDA) National Center for Toxicological Research (NCTR) awarded a multi-year contract to Xybion, a software and consulting firm that will aid in expediting research of new products and medicines.
Treatment approved for approximately 90% of patients with cystic fibrosis, many of whom had no approved therapeutic options
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.