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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 9 Jun 2014
Batu Biologics Announces FDA Development Plans for ValloVax(TM) Angiogenesis-Targeting Cancer Vaccine
Biopharmaceuticals Oncology
 HSMN NewsFeed - 9 Jun 2014
FDA Grants Edison Pharmaceuticals' EPI-743 Orphan Status for Leigh Syndrome
Biopharmaceuticals
 HSMN NewsFeed - 5 Jun 2014
Dehaier Receives CFDA Approval for Morpheus Ox Sleep Diagnostic Software
Devices Regulatory
 HSMN NewsFeed - 5 Jun 2014
QT Vascular Announces FDA Clearance of Chocolate PTCA Balloon Catheter
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 4 Jun 2014
CenterVue Announces FDA Clearance of Next Generation Macular Integrity Assessment (MAIA)
Devices Ophthalmology FDA
 HSMN NewsFeed - 4 Jun 2014
HeartWare International Comments On FDA Warning Letter
Devices Cardiology
 HSMN NewsFeed - 3 Jun 2014
SafeWire, LLC Receives 510(k) Clearance for Y-Wire(R) 2
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 2 Jun 2014
Omeros Receives FDA Approval of Omidria(TM) for Use in Cataract and Other Intraocular Lens Replacement Procedures
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 28 May 2014
Mallinckrodt Pharmaceuticals’ New Drug Application Accepted for Review by FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 May 2014
eNeura, Inc. Receives FDA Clearance for SpringTMS(R) Migraine Treatment Device
Devices Neurology FDA
 HSMN NewsFeed - 23 May 2014
Teva Received FDA Approval for QVAR(R) (beclomethasone dipropionate HFA) with Dose Counter
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 May 2014
RaySearch Laboratories: RaySearch receives 510(k) clearance for Pencil Beam Scanning with protons
Devices Oncology FDA
 HSMN NewsFeed - 23 May 2014
EkoSonic(R) Endovascular System Receives FDA Clearance for the Treatment of Pulmonary Embolism in the USA
Devices Interventional FDA
 HSMN NewsFeed - 21 May 2014
Baxter Provides U.S. Regulatory Update on HyQvia, Its Investigational Subcutaneous Treatment for Primary Immunodeficiency
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 May 2014
Proa(R) Medical Receives 510(k) Clearance from FDA for Brella-Spec(TM) Vaginal Speculum for Gynecological and Obstetrical Procedures
Devices FDA
 HSMN NewsFeed - 19 May 2014
Shire Plans to Submit a New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults
Biopharmaceuticals Ophthalmology
 HSMN NewsFeed - 15 May 2014
Mylan Applauds Court's Ruling Dismissing Teva's Suit Against FDA on Copaxone(R)
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 12 May 2014
FDA Approves ZONTIVITY(TM) (vorapaxar), First-in-Class PAR-1 Antagonist, for the Reduction of Thrombotic Cardiovascular Events in Patients with a History of Heart Attack or with Peripheral Arterial Disease
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 9 May 2014
Prima BioMed's CVac(TM) Granted Fast Track Designation by FDA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 May 2014
The BD MAX(TM) Enteric Bacterial Panel Receives FDA Clearance to Detect the Most Common Causes of Bacterial Gastroenteritis
Diagnostics FDA
 HSMN NewsFeed - 7 May 2014
FDA Approves BIOTRONIK Entovis Pacemaker System with ProMRI(R) Technology
Devices Cardiology FDA
 HSMN NewsFeed - 6 May 2014
FDA Approves EPANOVA for the Treatment of Adults with Severe Hypertriglyceridemia
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 May 2014
FDA Approves Conversion of Soliris(R) (eculizumab) Accelerated Approval in aHUS to Regular Approval for the Treatment of Patients with aHUS
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 May 2014
FDA Approves Inspire(R) Upper Airway Stimulation (UAS) Therapy for Obstructive Sleep Apnea
Devices FDA
 HSMN NewsFeed - 30 Apr 2014
FDA Approves New Liquid Form Of Treatment For Patients With Acute Lymphoblastic Leukemia (ALL) As Part Of A Combination Regimen
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Apr 2014
Novartis gains FDA approval for Zykadia(TM), first therapy for patients with ALK+ NSCLC previously treated with the ALK inhibitor crizotinib
Biopharmaceuticals Oncology
 HSMN NewsFeed - 29 Apr 2014
CryoLife Receives FDA 510(k) Clearance for PerClot(R) Topical Hemostatic Powder in the U.S.
Devices FDA
 HSMN NewsFeed - 28 Apr 2014
GS Medical USA Announces FDA Clearance and Launch of AnyPlus(R) T/PLIF Cage
Devices Neurosurgery Orthopaedic FDA Product Launch
 HSMN NewsFeed - 28 Apr 2014
Sorin Group Receives FDA Approval for the Mitroflow (TM) Aortic Heart Valve with New Phospholipid Reduction Treatment
Devices Cardiology FDA
 HSMN NewsFeed - 28 Apr 2014
GW Pharmaceuticals Announces That Sativex Receives Fast Track Designation From FDA in Cancer Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Apr 2014
CrossBay Medical, Inc. Announces FDA, Health Canada, and CE Mark Marketing Authorizations for SonoSure SonoHysterography and Endometrial Sampling Device
Devices Regulatory
 HSMN NewsFeed - 24 Apr 2014
FDA Approves Roche's HPV Test for First-Line Primary Screening for Cervical Cancer
Diagnostics Oncology FDA
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