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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 - 2 Jun 2016
FDA Grants Orphan Drug Designation to Debiopharm International SA's IAP Inhibitor Debio 1143 in the Treatment of Ovarian Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 31 May 2016
Allergan Receives FDA Approval of TEFLARO(R) (ceftaroline fosamil) for Pediatric Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 May 2016
BioVentrix receives FDA IDE Approval for its Pivotal Clinical Trial, ALIVE
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 25 May 2016
Roche announces the first FDA-approved CMV test for use in hematopoietic stem cell transplant recipients
Diagnostics FDA
 HSMN NewsFeed - 24 May 2016
Cynosure Receives FDA Clearance to Market New PicoSure(R) Energy Delivery System for Tattoos and Pigmented Lesions
Devices Dermatology FDA
 HSMN NewsFeed - 24 May 2016
Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 24 May 2016
Interventional Spine, Inc. announces FDA Clearance of Lordotic Opticage(TM)
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 19 May 2016
Pain Therapeutics Announces FDA Advisory Committee Meeting for REMOXY(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 May 2016
Boston Scientific Receives U.S. FDA Approval for Precision Montage(TM) MRI Spinal Cord Stimulator System
Devices Neurology FDA Product Launch
 HSMN NewsFeed - 16 May 2016
Orthofix Announces 510(k) Clearance and US Limited Market Launch of FORZA PTC Interbody Spacer System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 12 May 2016
FDA Clears Next-Generation Version of EndoGastric Solutions’ EsophyX(R) Device
Devices Gastroenterology FDA
 HSMN NewsFeed - 11 May 2016
Medicure Files Application for New AGGRASTAT(R) Product Format
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 9 May 2016
Theravance Biopharma Announces FDA Approval of Expanded Label for VIBATIV(R) (telavancin)
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 May 2016
U.S. FDA Expands IMBRUVICA(R) (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and New Indication for Small Lymphocytic Lymphoma (SLL) Patients
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 May 2016
Boston Scientific Announces U.S. FDA Approval of Navigation-Enabled Ablation Catheters
Devices Cardiology FDA Product Launch
 HSMN NewsFeed - 3 May 2016
Spinal Simplicity Lands Investor In Nueterra Capital, Advances Opportunity For FDA-Cleared Minuteman Fusion Device
Devices Orthopaedic Neurosurgery Venture Capital
 HSMN NewsFeed - 3 May 2016
First Ray Receives FDA 510(k) Clearance for Stealth Staple(TM)
Devices Orthopaedic Surgery FDA
 HSMN NewsFeed - 2 May 2016
Perrigo Announces FDA Approval and Launch of the Generic Version of BenzaClin(R) Pump Topical Gel
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 2 May 2016
Allergan Receives FDA Approval and Launches First Generic Version of CRESTOR(R) (rosuvastatin)
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 2 May 2016
Corsens Medical Ltd., Announces Filing of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Corsens Cardiac Monitor
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 29 Apr 2016
Boston Scientific Receives U.S. FDA Approval For ImageReady(TM) MR-Conditional Pacing System
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 27 Apr 2016
Novartis Receives Three FDA Breakthrough Therapy Designations for IlaristTo Treat Rare Types of Periodic Fever Syndromes
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Apr 2016
Intuity Medical Receives FDA Clearance to Market POGO(R) Automatic(TM) Blood Glucose Monitoring System
Diagnostics Devices Monitoring Endocrinology FDA
 HSMN NewsFeed - 26 Apr 2016
Hematogenix Laboratory Services, LLC (Hematogenix)- Announces the Launch of two U.S. Food and Drug Administration (FDA) Approved PD-L1 Companion Diagnostic Tests to Help Guide Oncologists Using Immuno-Oncology Therapies
Diagnostics Oncology Product Launch
 HSMN NewsFeed - 22 Apr 2016
Fiagon Receives FDA Clearance For Brain Surgery
Devices Neurosurgery FDA
 HSMN NewsFeed - 21 Apr 2016
FDA Grants Orphan Drug Designation For VAL-083 In Ovarian Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Apr 2016
Hologic Announces FDA Clearance and Commercial Availability of the Affirm(TM) Prone Biopsy System, the First 2D/3D(TM) Imaging-Guided Dedicated Prone Biopsy System
Devices Oncology Radiology FDA Product Launch
 HSMN NewsFeed - 20 Apr 2016
Oculus Innovative Sciences Receives U.S. FDA Approval for Lasercyn(TM) for Use Following Laser Procedures, Microdermabrasions and Chemical Peels
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 12 Apr 2016
AtriCure Announces 510(k) Clearance for the cryoFORM(TM) Cryoablation Probe
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 11 Apr 2016
FDA Grants Priority Review for Genentech’s Cancer Immunotherapy Atezolizumab in Specific Type of Lung Cancer
Biopharmaceuticals Personalized Medicine Oncology FDA
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