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FDA Approval Headlines from PR Newswire


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Muscle Warfare a wholly owned subsidiary of Embark Holdings (EMBK) passes inspection by the FDA
New Study Shows Full Spectrum Endoscopy Procedure Reduces The 'Miss Rate' of Adenomas During Colonoscopy
FDA Sets 17 July 2013 For MOXDUO® Advisory Committee Meeting
Thoratec Announces FDA Approval Of HeartMate II® Pocket Controller™
Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.
Mylan Launches Generic Tricor® Tablets
Syneron Introduces Enhancements to its Innovative Body Shaping Products
TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and Mainland China
SIMPONI® (golimumab) Receives FDA Approval for Ulcerative Colitis
Mylan Launches Generic Zomig® Tablets
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
MiE's PET SCINTRON Receives FDA Approval
TWi Pharmaceuticals Announces Tentative ANDA Approval for Guanfacine Hydrochloride Extended-Release Tablets
Arbor Pharmaceuticals Announces FDA Approval of First NDA
Breakthrough "AffloVest" Greatly Advances Respiratory Care
CitiusTech's BI-Clinical Platform for Healthcare BI & Analytics Receives NCQA HEDIS Certification
Neuralstem Principal Investigator, Dr. Eva Feldman, Presents Phase I ALS Trial Data At The Romanian Neurological Society Congress
Actavis' NDA for Progestin-Only Patch Accepted for Filing by FDA
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
BREO™ ELLIPTA™ gains US approval for the treatment of COPD
Novartis drug Ilaris® approved by FDA to treat active systemic juvenile idiopathic arthritis, a serious form of childhood arthritis
Tactical medical device is first of its kind
Hill-Rom Receives FDA 510(k) Clearance to Market MetaNeb 4.0 Airway Clearance System
FDA Grants Premarket Approval (PMA) For The SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy And EGD Procedures
FDA Clears Masimo rainbow® Acoustic Monitoring™ Sensor for Use on Pediatric Patients
FDA Grants Premarket Approval (PMA) For The SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy And EGD Procedures
Scioderm's SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa
Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Children and Adolescents with ADHD
Daratumumab Receives Breakthrough Therapy Designation in Double Refractory Multiple Myeloma from U.S. Food and Drug Administration
Clinical Results for Oramed's Oral Diabetes Treatment Published in Peer Reviewed Journal PLOS ONE
BiO2 Medical's IDE Application for the Angel™ Catheter Receives FDA Approval
Raptor Pharmaceutical's PROCYSBI™ Receives FDA Approval for the Treatment of Nephropathic Cystinosis
CSL Behring Receives FDA Approval of Kcentra™ for Urgent Warfarin Reversal in Patients with Acute Major Bleeding
NxStage Announces FDA Clearance for New High Flow Capabilities with NxStage System One
Putney Launches Generic of Baytril® Taste Tabs®
Scioderm's SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa
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
CVRx® Gains Full FDA Approval for Hypertension Study
Chenango County Now One of 15 Authorized Foreign-Trade Zones in NYS
Life Technologies Supports Global Effort to Help Accelerate Emergency Screening of Avian Influenza (H7N9) Virus
ResMed Noninvasive Ventilation Device Cleared by FDA for COPD Treatment
/K I L L K I L L K I L L - Axiom Worldwide, Inc./
Andrew Technologies Receives FDA 510 (k) Clearance for Autologous Fat Transfer with HydraSolve™ Lipoplasty System - First Liposuction Device with this Clearance.
InspireMD Receives Approval From US Food and Drug Administration to Begin US Regulatory Trial
FDA Approves Second Drug in BD Simplist™ Prefilled Injectable Line of Products
Fuisz Pharma Announces Intent to Divest Strategic Patent for Detection of Opioid Abuse; Seeks Offers for Patent through May 2013
Bausch + Lomb Signs Exclusive License Agreement with Paragon BioTeck for Phenylephrine
MedShape Announces FDA Clearance of New Soft Tissue Anchor for Fast Implantation in Tenodesis, Tendon Transfer Procedures
Neura Therapeutik Addresses FDA Concerns about Abuse, Misuse of Drugs with Development of Safe and Affordable Abuse-Deterrent Opioids
Abbott Announces FDA Approval and U.S. Launch of the TECNIS® Toric Intraocular Lens for Cataract Patients

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