Search: FDA Approval Headlines from PR Newswire < Go Back Press Statement on Behalf of the Singh Family (The Former Shareholders and Founders of Ranbaxy) Thu May 23 2013, 10:26 ET BioElectronics and Pulsed Shortwave Therapy Make Progress Thu May 23 2013, 8:30 ET Investigational New Drug Application Cleared by FDA for OMS824 in Huntington's Disease Thu May 23 2013, 7:00 ET Varian Medical Systems Receives FDA 510(k) Clearance of its Nexus DRF Digital X-Ray Imaging System Wed May 22 2013, 8:00 ET Bausch + Lomb Receives FDA Approval for the TRULIGN™ Toric Posterior Chamber Intraocular Lens Tue May 21 2013, 10:00 ET BioElectronics Presents FDA Reclassification Panel Tue May 21 2013, 8:30 ET Hologic Receives FDA Approval for a New Low-dose 3D Mammography (Breast Tomosynthesis) Solution for Breast Cancer Screening Tue May 21 2013, 8:15 ET Muscle Warfare a wholly owned subsidiary of Embark Holdings (EMBK) passes inspection by the FDA Mon May 20 2013, 7:00 ET New Study Shows Full Spectrum Endoscopy Procedure Reduces The 'Miss Rate' of Adenomas During Colonoscopy Sat May 18 2013, 10:00 ET FDA Sets 17 July 2013 For MOXDUO® Advisory Committee Meeting Fri May 17 2013, 9:00 ET Thoratec Announces FDA Approval Of HeartMate II® Pocket Controller™ Fri May 17 2013, 8:00 ET Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S. Fri May 17 2013, 7:50 ET Mylan Launches Generic Tricor® Tablets Fri May 17 2013, 7:30 ET Syneron Introduces Enhancements to its Innovative Body Shaping Products Thu May 16 2013, 9:00 ET TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and Mainland China Thu May 16 2013, 0:00 ET SIMPONI® (golimumab) Receives FDA Approval for Ulcerative Colitis Wed May 15 2013, 16:15 ET Mylan Launches Generic Zomig® Tablets Wed May 15 2013, 11:40 ET Bayer Receives U.S. FDA Approval for Xofigo® (radium Ra 223 dichloride) Injection as a New Treatment for Castration-Resistant Prostate Cancer with Bone Metastases Wed May 15 2013, 11:40 ET MiE's PET SCINTRON Receives FDA Approval Wed May 15 2013, 8:56 ET TWi Pharmaceuticals Announces Tentative ANDA Approval for Guanfacine Hydrochloride Extended-Release Tablets Tue May 14 2013, 7:54 ET Arbor Pharmaceuticals Announces FDA Approval of First NDA Mon May 13 2013, 17:30 ET Breakthrough "AffloVest" Greatly Advances Respiratory Care Mon May 13 2013, 15:14 ET CitiusTech's BI-Clinical Platform for Healthcare BI & Analytics Receives NCQA HEDIS Certification Mon May 13 2013, 11:13 ET Neuralstem Principal Investigator, Dr. Eva Feldman, Presents Phase I ALS Trial Data At The Romanian Neurological Society Congress Mon May 13 2013, 9:15 ET Actavis' NDA for Progestin-Only Patch Accepted for Filing by FDA Mon May 13 2013, 9:00 ET Endo Health Solutions Responds to FDA's Denial of OPANA® ER Citizen Petition and the Potential Approval of Additional Non-Abuse Deterrent Formulations of Generic Oxymorphone Fri May 10 2013, 16:56 ET BREO™ ELLIPTA™ gains US approval for the treatment of COPD Fri May 10 2013, 16:00 ET Novartis drug Ilaris® approved by FDA to treat active systemic juvenile idiopathic arthritis, a serious form of childhood arthritis Fri May 10 2013, 1:20 ET Tactical medical device is first of its kind Tue May 7 2013, 11:30 ET Hill-Rom Receives FDA 510(k) Clearance to Market MetaNeb 4.0 Airway Clearance System Mon May 6 2013, 16:00 ET FDA Grants Premarket Approval (PMA) For The SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy And EGD Procedures Mon May 6 2013, 8:30 ET FDA Clears Masimo rainbow® Acoustic Monitoring™ Sensor for Use on Pediatric Patients Mon May 6 2013, 8:00 ET FDA Grants Premarket Approval (PMA) For The SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy And EGD Procedures Fri May 3 2013, 18:32 ET Scioderm's SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa Fri May 3 2013, 14:51 ET Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Children and Adolescents with ADHD Wed May 1 2013, 15:45 ET Daratumumab Receives Breakthrough Therapy Designation in Double Refractory Multiple Myeloma from U.S. Food and Drug Administration Wed May 1 2013, 12:07 ET Clinical Results for Oramed's Oral Diabetes Treatment Published in Peer Reviewed Journal PLOS ONE Wed May 1 2013, 7:15 ET BiO2 Medical's IDE Application for the Angel™ Catheter Receives FDA Approval Wed May 1 2013, 7:00 ET Raptor Pharmaceutical's PROCYSBI™ Receives FDA Approval for the Treatment of Nephropathic Cystinosis Tue Apr 30 2013, 15:51 ET CSL Behring Receives FDA Approval of Kcentra™ for Urgent Warfarin Reversal in Patients with Acute Major Bleeding Tue Apr 30 2013, 10:13 ET NxStage Announces FDA Clearance for New High Flow Capabilities with NxStage System One Tue Apr 30 2013, 8:00 ET Putney Launches Generic of Baytril® Taste Tabs® Mon Apr 29 2013, 12:25 ET Scioderm's SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa Mon Apr 29 2013, 8:00 ET Oramed Pharmaceuticals to Present Results of its Key Clinical Studies of Oral Insulin in Type 1 Diabetes Patients at the GTC Diabetes Summit, Boston, MA; April 29-30, 2013 Mon Apr 29 2013, 7:40 ET CVRx® Gains Full FDA Approval for Hypertension Study Mon Apr 29 2013, 7:00 ET Chenango County Now One of 15 Authorized Foreign-Trade Zones in NYS Fri Apr 26 2013, 10:59 ET Life Technologies Supports Global Effort to Help Accelerate Emergency Screening of Avian Influenza (H7N9) Virus Fri Apr 26 2013, 8:00 ET ResMed Noninvasive Ventilation Device Cleared by FDA for COPD Treatment Thu Apr 25 2013, 8:00 ET /K I L L K I L L K I L L - Axiom Worldwide, Inc./ Wed Apr 24 2013, 9:08 ET Andrew Technologies Receives FDA 510 (k) Clearance for Autologous Fat Transfer with HydraSolve™ Lipoplasty System - First Liposuction Device with this Clearance. 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