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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 - 18 Nov 2016
Apricus Biosciences Provides Update on Vitaros NDA Following Receipt of FDA Feedback
Biopharmaceuticals Urology FDA
 HSMN NewsFeed - 17 Nov 2016
FDA Grants Fast Track Designation for Development of E2609, Eisai's BACE Inhibitor for Early Alzheimer's Disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 14 Nov 2016
Boston Biomedical Announces Orphan Drug Designation for Napabucasin in Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 Nov 2016
St. Jude Medical Announces Full-Body MRI Compatibility and Second Major Upgrade for Proclaim Elite Spinal Cord Stimulation System
Devices Neurology Radiology FDA Product Launch
 HSMN NewsFeed - 11 Nov 2016
Bristol-Myers Squibb’s Opdivo(R) (nivolumab) is the First Immuno-Oncology Treatment to Receive FDA Approval Based on Overall Survival in Head and Neck Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Nov 2016
KATOR Receives FDA Clearance for Knotless Suture Anchor System
Devices Orthopaedic Surgery FDA
 HSMN NewsFeed - 7 Nov 2016
Propeller Health Receives FDA Clearance for the Propeller Platform in Association with GSK's Ellipta(R) Inhaler
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 3 Nov 2016
FDA Accepts Genentech's Biologics License Application For Subcutaneous Formulation Of Rituximab
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 31 Oct 2016
Onkos Surgical(TM) Receives FDA 510(k) Clearance for ELEOS(TM) Limb Salvage System
Devices Oncology Surgery FDA
 HSMN NewsFeed - 31 Oct 2016
BD MAX(TM) Vaginal Panel Receives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections
Diagnostics FDA
 HSMN NewsFeed - 28 Oct 2016
Allergan Introduces RESTASIS MULTIDOSE(TM) (Cyclosporine Ophthalmic Emulsion) 0.05%, a New Delivery System for the One and Only FDA Approved Treatment to Help Patients Produce More of Their Own Tears
Biopharmaceuticals Ophthalmology FDA Product Launch
 HSMN NewsFeed - 28 Oct 2016
FDA Clears VITROS(R) Automation Solutions from Ortho Clinical Diagnostics
Diagnostics FDA Product Launch
 HSMN NewsFeed - 27 Oct 2016
NuVasive Secures Magnetic Resonance (MR) FDA Conditional Clearance for MAGEC System
Devices Orthopaedic Radiology FDA
 HSMN NewsFeed - 26 Oct 2016
RTI Surgical Announces Additional 510(k) Clearance for the Streamline(R) OCT System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 25 Oct 2016
Agilent Technologies Receives Expanded FDA Approval for Use of Dako PD-L1 IHC 22C3 pharmDx Companion Diagnostic in Non-Small Cell Lung Cancer (NSCLC)
Diagnostics Oncology FDA
 HSMN NewsFeed - 24 Oct 2016
aTyr Pharma Receives FDA Fast Track Designation for Resolaris(TM) to Treat Facioscapulohumeral Muscular Dystrophy (FSHD)
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Oct 2016
Medicrea Announces 2 FDA Clearances of New Specialized Components for Pediatric Deformity on PASS(R) and LigaPASS(R) Platforms for Complex Spine in Younger Patients
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 17 Oct 2016
Teleflex Receives FDA Clearance for the Arrow(R) Midline with Chlorag+ard(R) Technology
Devices FDA
 HSMN NewsFeed - 14 Oct 2016
Philips Receives FDA 510(k) Clearance for Lumify's S4-1 Transducer Bringing New Capabilities, Including Cardiac Imaging, to this Smart-Device Ultrasound
Devices Cardiology FDA
 HSMN NewsFeed - 13 Oct 2016
Chromocell and Astellas Announce FDA Fast Track Designation and First Subject Dosing with Lead Candidate CC8464/ASP1807 for the Management of Neuropathic Pain Associated with iSFN
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 11 Oct 2016
Neurocrine Announces INGREZZA(TM) (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by U.S. FDA
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 11 Oct 2016
FDA Grants Priority Review to Genentech’s Lucentis(R) (Ranibizumab Injection) Supplemental Biologics License Application for Myopic Choroidal Neovascularization
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 10 Oct 2016
St. Jude Medical Announces FDA Clearance and Launch of the New PressureWire X Guidewire Designed to Optimize PCI Procedures in Patients With Complex Anatomies
Devices Interventional Cardiology FDA Product Launch
 HSMN NewsFeed - 10 Oct 2016
Teleflex Receives FDA Clearance for ARROW(R)JACC with Chlorag+ard(R) Technology and Tunneler
Devices FDA
 HSMN NewsFeed - 7 Oct 2016
Fresenius Kabi Receives FDA 510(k) Clearance for the Aurora(TM) Xi Plasmapheresis System
Devices FDA
 HSMN NewsFeed - 6 Oct 2016
U.S. FDA Approves Orexo's Low Dose ZUBSOLV(R) Buprenorphine and Naloxone Sublingual Tablets (CIII)
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Oct 2016
Trice Medical Receives FDA 510(K) Clearance for mi-eye 2
Devices Orthopaedic FDA
 HSMN NewsFeed - 5 Oct 2016
SonaCare Medical Paves the Way with the First HIFU Device Cleared by the FDA for Prostate Tissue Ablation - A Year in Review
Devices FDA
 HSMN NewsFeed - 5 Oct 2016
FDA Approves Continued Access to ReCell(R) in US Burns Trial
Devices Regenerative Medicine FDA
 HSMN NewsFeed - 29 Sep 2016
Allergan Issues Statement on Namenda XR Patent Litigation Following Announcement of ANDA Approvals
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 29 Sep 2016
Next Science(TM) Irrigation Solution Gains FDA Approval
Biopharmaceuticals Wound Care FDA
 HSMN NewsFeed - 28 Sep 2016
Abbott Receives FDA Approval for the FreeStyle Libre Pro(TM) System, a Revolutionary Diabetes Sensing Technology for Healthcare Professionals to Use with Their Patients
Devices Monitoring Endocrinology FDA
 HSMN NewsFeed - 26 Sep 2016
Roche Receives 510(K) Clearance from FDA for Treponema Pallidum Assay to Aid Clinicians in the Diagnosis of Syphilis Infection
Diagnostics FDA
 HSMN NewsFeed - 26 Sep 2016
AbbVie Announces Submission of a Supplemental New Drug Application for Ibrutinib (IMBRUVICA(R)) for Treatment of Marginal Zone Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 26 Sep 2016
MOTUS GI(TM) Receives FDA Clearance to Market the Pure-Vu(TM) System for Cleansing Poorly Prepared Colons During Colonoscopy
Devices Gastroenterology Oncology FDA
 HSMN NewsFeed - 26 Sep 2016
Regeneron and Sanofi Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA
Biopharmaceuticals Dermatology FDA
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