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Healthcare News Roundup: FDA

 HSMN NewsFeed - 31 May 2018
Curis Announces FDA Fast Track Designation for Fimepinostat Development in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 May 2018
Legend Announces FDA Clearance of IND Application on CAR-T Immuno-cell Therapy for the Treatment of Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 May 2018
FDA expedites review of Novartis drug Promacta(R) for first-line severe aplastic anemia (SAA)
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 May 2018
FDA Broadens ClearGuard(R) HD Antimicrobial Barrier Cap Indications
Devices FDA
 HSMN NewsFeed - 29 May 2018
TrioxBio Announces Fast Track Designation Granted by U.S. FDA to Raviten(R) for the Treatment of Intradialytic Hypotension
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 May 2018
Zeto Announces First Dry Electrode, Wireless EEG Headset Approved by FDA for Clinical Use
Devices Monitoring Neurology FDA
 HSMN NewsFeed - 29 May 2018
U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 May 2018
EmeTerm Anti-Nausea and Vomiting Wristband is FDA Cleared
Devices Neurology Product Launch
 HSMN NewsFeed - 21 May 2018
CERENOVUS Receives FDA Clearance For Next Generation Stent Retriever Device Used To Treat Ischemic Stroke
Devices Interventional Radiology Neurology FDA
 HSMN NewsFeed - 21 May 2018
Nestlé Skin Health Announces the FDA Approval of Restylane(R) Lyft for Hands, the First and Only Hyaluronic Acid (HA) Dermal Filler for Use in the Back of Hands
Devices Dermatology FDA
 HSMN NewsFeed - 18 May 2018
FDA Approves Aimovig(TM) (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention
Biopharmaceuticals Devices Drug Delivery FDA
 HSMN NewsFeed - 17 May 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 15 May 2018
Caliber Imaging & Diagnostics, Inc. Announces FDA 510(k) Clearance for its VIVASCOPE System
Devices Dermatology FDA
 HSMN NewsFeed - 15 May 2018
FDA Clears Expanded Claims for 'Superbug' Test
Diagnostics FDA
 HSMN NewsFeed - 14 May 2018
Immunicom's Immunotherapy Product Receives U.S. FDA Breakthrough Device Designation for the Treatment of Cancer
Devices Oncology FDA
 HSMN NewsFeed - 14 May 2018
CurveBeam Announces FDA 510(k) Clearance for LineUP Weight Bearing Multi-Extremity CT System
Devices Radiology Orthopaedic FDA
 HSMN NewsFeed - 14 May 2018
FDA approves additional claim for Roche cobas Zika test
Diagnostics FDA
 HSMN NewsFeed - 7 May 2018
CardioFocus(R) Announces FDA Approval Of The Next-Generation HeartLight(R) Excalibur Balloon(TM) Designed For The Treatment Of Paroxysmal Atrial Fibrillation
Devices Cardiology FDA
 HSMN NewsFeed - 7 May 2018
Salix Receives FDA Approval For PLENVU(R), Next Generation 1-Liter Bowel Cleansing Preparation For Colonoscopies
Biopharmaceuticals Radiology Gastroenterology FDA
 HSMN NewsFeed - 3 May 2018
Abbott Expands Cardiac Arrhythmias Portfolio with FDA Clearance of Advanced Mapping Catheter
Devices Cardiology FDA
 HSMN NewsFeed - 3 May 2018
Exact Imaging Receives FDA 510(k) Clearance for Adding the FusionVu Application to the ExactVu(TM) Micro-Ultrasound Platform
Devices Urology Oncology FDA
 HSMN NewsFeed - 2 May 2018
Bausch & Lomb ULTRA(R) Contact Lenses Receive FDA Approval for Extended Wear Indication
Devices Ophthalmology FDA
 HSMN NewsFeed - 2 May 2018
Paradigm Spine Receives FDA Pre-Market Approval (PMA) For First Of Its Kind Disposable Instrument Kit
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 1 May 2018
SCYNEXIS's Oral SCY-078 Receives FDA QIDP and Fast Track Designations for the Treatment of VVC and Prevention of Recurrent VVC
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Apr 2018
Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT(R) (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Apr 2018
FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 26 Apr 2018
Agfa Receives FDA 510(k) Clearance for DR 800 Multi-purpose Digital Imaging System
Devices Radiology FDA
 HSMN NewsFeed - 25 Apr 2018
FDA Grants Fast Track Designation for OrphoMed's ORP-101 for Treatment of IBS-D
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 25 Apr 2018
FDA Approval of ThinPrep(R) Integrated Imager Expands Automated Imaging for Pap Testing to More Labs
Devices Diagnostics Oncology FDA
 HSMN NewsFeed - 24 Apr 2018
Lin BioScience Announces FDA Orphan Drug Designation for LBS-007 for the Treatment of Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Apr 2018
Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter
Devices Interventional FDA
 HSMN NewsFeed - 23 Apr 2018
Amerigen and Dipharma Announce U.S. FDA Approval for Generic Miglustat 100 mg Capsules
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 20 Apr 2018
Helsinn Group announces the FDA approval of the IV formulation of AKYNZEO(R) (fosnetupitant/ palonosetron) in the United States
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Apr 2018
FDA Accepts Veloxis's Supplemental New Drug Application for the De Novo Indication for ENVARSUS XR(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Apr 2018
King-Devick technologies receives FDA clearance for K-D Balance(TM) App
Devices FDA
 HSMN NewsFeed - 16 Apr 2018
Roche receives FDA clearance for cobas(R) CT/NG for cobas(R) 6800/8800 Systems
Diagnostics FDA
 HSMN NewsFeed - 12 Apr 2018
FDA Permits Marketing of IDx-DR for Automated Detection of Diabetic Retinopathy in Primary Care
Devices Ophthalmology FDA Product Launch
 HSMN NewsFeed - 12 Apr 2018
TransMedics, Inc. Receives FDA Pre-Market Approval (PMA) for its OCS(TM) Lung System for Near-Physiologic Preservation and Assessment of Lungs for Transplantation
Devices Surgery FDA
 HSMN NewsFeed - 9 Apr 2018
Fischer Medical Receives U.S. FDA 510(k) Clearance to Market Bloom2 Cardiac Stimulator
Devices Cardiology FDA
 HSMN NewsFeed - 9 Apr 2018
RegeneRx Announces Outcome of FDA Discussions for Development of RGN-259 for Dry Eye Syndrome
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 6 Apr 2018
Teligent, Inc. Announces FDA Approval of Ciclopirox Shampoo, 1%
Biopharmaceuticals Generics FDA
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