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Healthcare News Roundup: FDA

 HSMN NewsFeed - 21 Apr 2010
Akorn Announces FDA Approval to Re-Launch Erythromycin Ophthalmic Ointment USP 3.5 g
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 21 Apr 2010
Medtronic Receives FDA Approval for New Indication for Complete(R) SE Vascular Stent
Devices Interventional FDA
 HSMN NewsFeed - 21 Apr 2010
Proteus Announces FDA Clearance of Wireless Personal Health Monitor
Devices Monitoring FDA
 HSMN NewsFeed - 19 Apr 2010
Sagent Pharmaceuticals Announces FDA Approval of Mesna Injection
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 19 Apr 2010
Mylan Announces Approval Under PEPFAR for Generic Version of Videx(R) EC HIV Treatment
Biopharmaceuticals Generics HIV/AIDS FDA
 HSMN NewsFeed - 19 Apr 2010
Roxane Laboratories, Inc. Announces the Launch of Imipramine Pamoate Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 15 Apr 2010
Contura Submits Registration Application for Aquamid(R) to the FDA
Devices Dermatology FDA
 HSMN NewsFeed - 14 Apr 2010
Sagent Pharmaceuticals Announces FDA Approval of Granisetron Hydrochloride Injection, USP
Biopharmaceuticals Generics Oncology FDA
 HSMN NewsFeed - 14 Apr 2010
Hybridyne Imaging Technologies Receives FDA Clearance for New Medical Imaging System
Devices Oncology FDA
 HSMN NewsFeed - 14 Apr 2010
Terumo Heart, Inc. Submits IDE to FDA for U.S. Destination Therapy Trial for the DuraHeart(TM) Left Ventricular Assist System
Devices Cardiology FDA
 HSMN NewsFeed - 13 Apr 2010
FDA Maintains Essential Use Status of Combivent(R) (ipratropium bromide and albuterol sulfate) Inhalation Aerosol Through 2013
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Apr 2010
FDA Approves New Drug Application for PANCREAZE(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Apr 2010
Sinapis Pharma Receives IND Approval from the FDA
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 10 Apr 2010
First Comprehensive LASIK Treatment of Astigmatism Approved by the FDA
Devices Ophthalmology FDA
 HSMN NewsFeed - 9 Apr 2010
Vasomedical Announces FDA 510(k) Clearance on the First Combined ECG Holter and Ambulatory Blood Pressure Monitoring System
Devices Monitoring FDA
 HSMN NewsFeed - 9 Apr 2010
Vitala(TM) Continence Control Device Receives 510(K) Clearance From U.S. Food and Drug Administration
Devices FDA
 HSMN NewsFeed - 9 Apr 2010
CTI Receives Complete Response Letter from the FDA for Pixantrone NDA; CTI to File for Expanded Access for Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Apr 2010
Teva Announces Final Approval of Generic Hyzaar(R) and Cozaar(R)
Biopharmaceuticals Generics Cardiology FDA
 HSMN NewsFeed - 6 Apr 2010
Cataract Treatment Gets More Precise With FDA Approval of Softec HD(TM) Lens
Devices Ophthalmology FDA
 HSMN NewsFeed - 6 Apr 2010
Baxter and Nycomed Announce FDA Approval of TachoSil(R)
Devices Surgery FDA
 HSMN NewsFeed - 6 Apr 2010
Allon Therapeutics Announces Davunetide Receives FDA Fast Track Status for Treatment of Progressive Supranuclear Palsy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 6 Apr 2010
Genta's Tesetaxel Granted Fast Track Designation by FDA for Advanced Gastric Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Apr 2010
Imaging3 Announces FDA Submission
Devices FDA
 HSMN NewsFeed - 5 Apr 2010
The Canon CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera Receives FDA Clearance
Devices Ophthalmology FDA
 HSMN NewsFeed - 5 Apr 2010
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Refractory Advanced Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 Apr 2010
Tioga Pharmaceuticals Receives Special Protocol Assessment Agreement From FDA for Phase 3 Trials of Asimadoline in Irritable Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 1 Apr 2010
ProUroCare Medical Announces Receipt of Letter from FDA on 510(k)
Devices Urology FDA
 HSMN NewsFeed - 31 Mar 2010
Abbott Submits Test to Aid in Identifying Patients at Risk of Developing Kidney Injury
Diagnostics FDA
 HSMN NewsFeed - 31 Mar 2010
AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Candida Bloodstream Pathogens
Diagnostics FDA
 HSMN NewsFeed - 30 Mar 2010
Bovie Medical Corporation Announces 510(K) Application for a New Office Based High Frequency Electrosurgical Generator
Devices Surgery FDA
 HSMN NewsFeed - 30 Mar 2010
AstraZeneca and Abbott Receive FDA Complete Response Letter on CERTRIAD(TM) New Drug Application
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Mar 2010
FDA Approves Zyclara(TM) (imiquimod) Cream, 3.75% for the Treatment of Actinic Keratoses
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 26 Mar 2010
AngioScore Announces 510(k) Clearance to Market AngioSculpt Scoring Balloon Catheter for Renal Indications
Devices FDA Interventional
 HSMN NewsFeed - 26 Mar 2010
VIVUS Announces Date of FDA Advisory Committee Review of Qnexa(R) for the Treatment of Obesity
Biopharmaceuticals
 HSMN NewsFeed - 25 Mar 2010
Guided Therapeutics LightTouch Cervical Scan FDA Clinical Trial Indicates Adolescent's Risk for Cervical Disease on Par with Adult Women
Devices Diagnostics Oncology
 HSMN NewsFeed - 25 Mar 2010
Teva Announces Tentative Approval of Generic Argatroban(R) Injection
Biopharmaceuticals Cardiology Generics FDA
 HSMN NewsFeed - 25 Mar 2010
Riverain Medical Receives FDA Clearance for SoftView Enhanced Chest Imaging
Devices Radiology Oncology FDA
 HSMN NewsFeed - 24 Mar 2010
FDA Approves XIFAXAN(R) 550 MG Tablets for Reduction in Risk of Overt Hepatic Encephalopathy (HE) Recurrence
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Mar 2010
Guided Therapeutics' LightTouch Cervical Scan Detected Disease Up to Two Years Earlier Than Pap, HPV and Biopsy in FDA Pivotal Clinical Trial
Devices Diagnostics Oncology
 HSMN NewsFeed - 24 Mar 2010
Custom Spine Receives FDA Clearance for PATHWAY ACIF
Devices FDA Neurosurgery Orthopaedic
 HSMN NewsFeed - 23 Mar 2010
Once-Daily MIRAPEX ER Now Approved by FDA for Both Early and Advanced Parkinson's Disease
Biopharmaceuticals FDA Neurology
 HSMN NewsFeed - 23 Mar 2010
OrSense Receives U.S. FDA Approval for NMB-200MP Non-Invasive Oximetry Monitoring System
Devices Monitoring FDA
 HSMN NewsFeed - 23 Mar 2010
APP Pharmaceuticals Receives Approval for Indomethacin for Injection
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 22 Mar 2010
Utah Medical Products, Inc. Announces Conclusion of FDA Inspection
Devices FDA
 HSMN NewsFeed - 22 Mar 2010
BSD Medical Files FDA 510(k) Submission to Market Phase II MicroThermX Ablation System
Devices Surgery Oncology FDA
 HSMN NewsFeed - 19 Mar 2010
Medtronic Receives FDA Panel's Unanimous Recommendation for Approval of Revo MRI SureScan Pacing System
Devices Cardiology
 HSMN NewsFeed - 19 Mar 2010
Bovie Medical Corporation Announces Clearance to Market Its BOSS Soft Tissue Coagulation Device
Devices Surgery FDA
 HSMN NewsFeed - 19 Mar 2010
Stemedica Files IND Application With FDA for Treatment of Stroke With Adult Allogeneic Mesenchymal Stem Cells
Regenerative Medicine Neurology
 HSMN NewsFeed - 18 Mar 2010
Somaxon Announces FDA Approval of Silenor(R) (doxepin) for the Treatment of Insomnia
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Mar 2010
Cameron Health Commences FDA-Approved IDE Clinical Trial of the Minimally Invasive Totally Subcutaneous Implantable Defibrillator for Treatment of Sudden Cardiac Arrest
Devices Cardiology
 HSMN NewsFeed - 17 Mar 2010
FDA Approves First of Its Kind, Fully Implantable (Surgically), Invisible, Prosthetic Hearing Restoration Device
Devices FDA
 HSMN NewsFeed - 17 Mar 2010
Medtronic Completes Pre-Market Approval Submission to FDA for Arctic Front(R) Cardiac CryoAblation Catheter System
Devices Cardiology FDA
 HSMN NewsFeed - 17 Mar 2010
FDA Accepts Filing of Ondine's Pre-Market Approval (PMA) Application for Periowave(TM) Photodisinfection System
Devices Dental FDA
 HSMN NewsFeed - 17 Mar 2010
Medtronic Receives FDA Approval for Industry's Most Advanced Integrated System for Diabetes Management
Devices Endocrinology FDA
 HSMN NewsFeed - 17 Mar 2010
RaySearch receives 510(k) Clearance For RayStation
Devices Oncology FDA
 HSMN NewsFeed - 16 Mar 2010
Genentech Submits Supplemental Biologics License Application for ACTEMRA(R) (tocilizumab) for Prevention of Structural Joint Damage and Improvement of Physical Function in Rheumatoid Arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Mar 2010
BIOLASE Announces FDA 510(K) Clearance of iLase (TM) Personal Laser for Dental Market
Devices Dental FDA
 HSMN NewsFeed - 15 Mar 2010
Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission
Biopharmaceuticals
 HSMN NewsFeed - 12 Mar 2010
FDA Panel Recommends Approval with Conditions of Medtronic Deep Brain Stimulation Therapy for Patients with Refractory Epilepsy
Devices Neurology FDA
 HSMN NewsFeed - 12 Mar 2010
Bovie Medical Corporation Announces Clearance to Market Its ICON VS Electrosurgical Generator
Devices Surgery FDA
 HSMN NewsFeed - 11 Mar 2010
FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 11 Mar 2010
FDA Approves Boston Scientific's Express(R) LD Iliac Stent System
Devices Interventional FDA
 HSMN NewsFeed - 11 Mar 2010
New Introducer Product Line from St. Jude Medical Offers Reliable Access and Facilitates Arterial Closure
Devices Interventional FDA Regulatory
 HSMN NewsFeed - 11 Mar 2010
Rex Medical Cleaner Rotational Thrombectomy System Receives 510(k) Clearance
Devices Interventional FDA
 HSMN NewsFeed - 10 Mar 2010
Oculus Innovative Sciences Receives First FDA Clearance for Microcyn®-Based HydroGel for Dermatology Market with Claims Including Reduction of Itch and Pain Relief
Devices Wound Care Dermatology FDA
 HSMN NewsFeed - 10 Mar 2010
Cytokinetics Announces Orphan Drug Designation Granted to CK-2017357 for the Treatment of Amyotrophic Lateral Sclerosis
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 10 Mar 2010
Abbott Receives U.S. FDA Approval for New Cataract Multifocal Intraocular Lens
Devices Ophthalmology FDA
 HSMN NewsFeed - 9 Mar 2010
ETEX Corporation Announces FDA Clearance and Launch of Carrigen(R) Porous Bone Substitute Material
Devices Orthopaedic FDA
 HSMN NewsFeed - 9 Mar 2010
Medifocus, Inc. Announces That It Has Received Approval to Initiate Its Pivotal Phase III Clinical Trial for Treatment of Breast Cancer from the Food and Drug Administration (FDA), Investigational Device Exemption (IDE) Application
Devices Oncology FDA
 HSMN NewsFeed - 9 Mar 2010
FDA Clears GeNO LLC Investigational New Drug Application for Nitric Oxide Delivery System
Devices Drug Delivery
 HSMN NewsFeed - 8 Mar 2010
ThermalTherapeutic Systems Announces FDA Clearance of the VERATHERM(TM) Portable Hyperthermic Perfusion System
Devices FDA
 HSMN NewsFeed - 3 Mar 2010
FDA Provides 510k Clearance for BARRX Medical's HALO90 Ablation Catheter for the Treatment of Radiation Proctitis and Gastric Antral Vascular Ectasia (GAVE)
Devices Gastroenterology FDA
 HSMN NewsFeed - 3 Mar 2010
Novo Nordisk Receives FDA Approval for Norditropin(R) FlexPro(R) for Growth Hormone Treatment
Biopharmaceuticals Devices Drug Delivery FDA
 HSMN NewsFeed - 3 Mar 2010
CaridianBCT Receives 510(k) Clearance on Latest Version of Trima Accel Automated Blood Collection System
Devices FDA
 HSMN NewsFeed - 2 Mar 2010
OrthoDynamix LLC Receives FDA 510(k) Clearance for ArthroSteer(R) 3.5mm Ablator
Devices Orthopaedic Surgery FDA
 HSMN NewsFeed - 2 Mar 2010
FDA Classifies Baxter's January HomeChoice Peritoneal Dialysis Cycler Field Corrective Action as a Class I Recall
Devices Product Recall FDA
 HSMN NewsFeed - 2 Mar 2010
Impax Laboratories Receives Final FDA Approval for Generic FLOMAX(R) 0.4mg Capsules and Immediately Commences Shipment
Biopharmaceuticals FDA Generics
 HSMN NewsFeed - 2 Mar 2010
FDA Approves EXALGO (Hydromorphone HCL) Extended-Release Tablets
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Mar 2010
FDA Advisory Committee Recommends Approval of Belatacept, an Investigational Agent for Prophylaxis of Acute Rejection in De Novo Kidney Transplant Patients
Biopharmaceuticals
 HSMN NewsFeed - 1 Mar 2010
FDA Accepts VIAject(R) NDA for Review
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 1 Mar 2010
ADVENTRX Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
Biopharmaceuticals
 HSMN NewsFeed - 26 Feb 2010
Arena Pharmaceuticals Receives PDUFA Date for Lorcaserin NDA
Biopharmaceuticals FDA
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