Healthcare Sales & Marketing Network: FDA News Roundup

Healthcare News Roundup: FDA

HSMN NewsFeed - 22 Jun 2018
Impel NeuroPharma Announces FDA Clearance of IND for Pivotal Phase 3 Study of INP104 for Acute Treatment of Migraine
Biopharmaceuticals Drug Delivery Neurology FDA

HSMN NewsFeed - 20 Jun 2018
Medtronic Announces Second Bone Cement Solution Indicated for Treating Sacral Fractures
Devices Interventional Radiology Orthopaedic FDA

HSMN NewsFeed - 20 Jun 2018
AIVITA Biomedical Announces U.S. Food and Drug Administration Clearance of IND for Phase II Glioblastoma Multiforme Trial
Regenerative Medicine Oncology FDA

HSMN NewsFeed - 19 Jun 2018
Grifols Expands its NAT Solutions Portfolio with New FDA Approvals for Two Assays
Diagnostics FDA

HSMN NewsFeed - 18 Jun 2018
Arcuro Medical Receives FDA Regulatory Clearance
Devices Orthopaedic FDA

HSMN NewsFeed - 15 Jun 2018
Medtronic Receives FDA Approval for 200mm & 250mm IN.PACT(TM) Admiral(TM) Drug Coated Balloons
Devices Interventional FDA

HSMN NewsFeed - 14 Jun 2018
BlueWind Medical Receives FDA Approval for Pivotal Trial Design of RENOVA iStim(TM) Implantable Tibial Nerve Neuromodulator for Overactive Bladder
Devices Urology Neurology FDA

HSMN NewsFeed - 12 Jun 2018
MicroVention Announces FDA Clearance For Thrombectomy Device
Devices Interventional Neurology FDA

HSMN NewsFeed - 11 Jun 2018
OrthoSensor, Inc. Secures Additional 510(K) Clearance
Devices Orthopaedic FDA

HSMN NewsFeed - 7 Jun 2018
Centinel Spine Announces 510(k) Clearance of FLX(TM) Platform of 3D Printed All-Titanium Interbodies
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 6 Jun 2018
Partner Therapeutics (PTx) Announces US FDA Approval of Leukine(R) (sargramostim) for the Treatment of Acute Radiation Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Jun 2018
Philips receives U.S. FDA 510(k) clearance for its Ingenia Elition MR solution
Devices Radiology FDA

HSMN NewsFeed - 5 Jun 2018
FDA Expands Lilly's ALIMTA(R) (pemetrexed) Label to Include Combination with KEYTRUDA(R) (pembrolizumab) and Carboplatin as First-Line Treatment for Metastatic Nonsquamous Non-Small Cell Lung Cancer, Irrespective of PD-L1 Expression
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Jun 2018
Camber Spine Announces 510(k) Approval Of ENZA(TM)-A Titanium ALIF
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 1 Jun 2018
Lannett Receives FDA Approval For Levofloxacin Oral Solution; Imminent Launch Anticipated
Biopharmaceuticals Generics FDA Product Launch

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 - 31 May 2018
Encision Inc. Applauds the FDA's Safety Communication On The Dangers Of Monopolar Electrosurgery
Devices Surgery 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
UCB Announces the Approval of CIMZIA(R) (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis, Representing an Important New Option for Patients in the U.S.
Biopharmaceuticals Dermatology 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 - 23 May 2018
Newest Generation of Leading Heart Stent is Now Approved in the U.S. for People with Coronary Artery Disease
Devices Interventional Cardiology FDA

HSMN NewsFeed - 22 May 2018
FAST Study Demonstrates High Diagnostic Accuracy of CAAS vFFR and Received USA 510(k) Market Clearance
Devices Interventional Cardiology 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
Nestl� 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

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