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Healthcare News Roundup: FDA

 HSMN NewsFeed - 14 Dec 2017
Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi(TM) (ozenoxacin) Cream, 1%, a Novel Topical Antibiotic for Impetigo
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 12 Dec 2017
FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Dec 2017
Allergan Receives FDA Clearance For the CoolSculpting(R) Treatment To Improve Appearance Of Lax Tissue In The Double Chin
Devices Dermatology FDA
 HSMN NewsFeed - 11 Dec 2017
Polaryx Therapeutics Receives Orphan Drug Designation From the US FDA for the Treatment of Neuronal Ceroid Lipofuscinoses With PLX-100
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 11 Dec 2017
Regeneron Announces FDA Acceptance of sBLA Filing for 12-Week Dosing of EYLEA(R) (aflibercept) Injection for Patients with Wet AMD
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 11 Dec 2017
FDA Accepts Biologics License Application (BLA) to Review Galcanezumab for the Prevention of Migraine in Adults
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Dec 2017
Impax Receives Tentative FDA Approval of Generic Coreg CR(R) (Carvedilol Phosphate) Extended-Release Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 7 Dec 2017
VitalConnect Secures Fifth U.S. FDA Clearance for Patient Monitoring Device
Devices Monitoring FDA
 HSMN NewsFeed - 7 Dec 2017
Camber Spine Announces FDA Clearance Of Spira(TM)-C Open Matrix Cervical Interbody
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 6 Dec 2017
ImpediMed Launches FDA-Approved SOZO(TM)
Devices Product Launch
 HSMN NewsFeed - 6 Dec 2017
Sirnaomics' Leading siRNA Therapeutic Candidate, STP705, Granted Orphan Designation for Treatment of Cholangiocarcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Dec 2017
Third Respiratory Assay Now FDA Cleared on Hologic's New Panther Fusion(R) System
Diagnostics FDA Product Launch
 HSMN NewsFeed - 5 Dec 2017
Lia Diagnostics Announces FDA Clearance Of The First And Only Flushable, Biodegradable Pregnancy Test
Diagnostics FDA
 HSMN NewsFeed - 5 Dec 2017
EMD Serono Announces FDA 510(k) Clearance of Partner Genea Biomedx's Fertility Benchtop Incubator Geri(TM)
Devices FDA
 HSMN NewsFeed - 4 Dec 2017
Spruce Biosciences Receives FDA Orphan Drug Designation for SPR001 for the Treatment of Congenital Adrenal Hyperplasia
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Dec 2017
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Nov 2017
RICOH MEG Receives FDA 510(k) Clearance
Devices Radiology Neurology FDA
 HSMN NewsFeed - 30 Nov 2017
Cordis and Medinol Announce FDA Approval of the Innovative EluNIR Drug-Eluting Stent System
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 30 Nov 2017
FDA Clears First Medical Device Accessory for Apple Watch(R)
Devices Cardiology FDA
 HSMN NewsFeed - 29 Nov 2017
FDA-Approved Cefaly(R) Device to Stop Migraines Now Available
Devices Neurology FDA Product Launch
 HSMN NewsFeed - 29 Nov 2017
Capricor Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for CAP-1002
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Nov 2017
Upsher-Smith Launches KLOR-CON(R) Powder (Potassium Chloride) For Oral Solution
Biopharmaceuticals FDA Product Launch
 HSMN NewsFeed - 28 Nov 2017
GenePOC Launches its GenePOC(TM) CDiff Test in the United States
Diagnostics FDA Product Launch
 HSMN NewsFeed - 27 Nov 2017
FDA Approves First Study of INSIGHTEC's Exablate Neuro to Open the Blood-Brain Barrier in Glioblastoma Patients
Devices Oncology FDA
 HSMN NewsFeed - 27 Nov 2017
Stealth BioTherapeutics Granted Fast Track Designation for the Treatment of Barth Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Nov 2017
FDA Clearance For Perspectum Diagnostics' LiverMultiScan(TM) Means More Patients Can Benefit From Access To State-Of-The-Art Non-Invasive Diagnostic Aid For Liver Disorders
Diagnostics Radiology FDA
 HSMN NewsFeed - 27 Nov 2017
Pharming Submits Supplemental Biologics License Application to FDA for RUCONEST(R) for Prophylaxis of Hereditary Angioedema Attacks
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Nov 2017
Hologic Receives FDA 510(k) Clearance of Quantra(TM) 2.2 Breast Density Assessment Software
Devices Radiology Oncology FDA
 HSMN NewsFeed - 20 Nov 2017
U.S. FDA Approves Kaléo's AUVI-Q(R) (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children
Biopharmaceuticals Devices Drug Delivery FDA
 HSMN NewsFeed - 20 Nov 2017
United Therapeutics Announces Additional Six Months Of Regulatory Exclusivity For Adcirca(R)
Biopharmaceuticals FDA Licensing
 HSMN NewsFeed - 17 Nov 2017
MiMedx Market Leadership Well Positioned In Light Of FDA New Guidance Document
Regenerative Medicine FDA
 HSMN NewsFeed - 16 Nov 2017
FDA Approves New Treatment to Prevent Bleeding in Certain Patients with Hemophilia A
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Nov 2017
FDA Announces Comprehensive Regenerative Medicine Policy Framework
Regenerative Medicine FDA
 HSMN NewsFeed - 15 Nov 2017
Noden Pharma Announces FDA Approval of Tekturna(R) (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 14 Nov 2017
FDA warns about illegal use of injectable silicone for body contouring and associated health risks
Devices Dermatology FDA
 HSMN NewsFeed - 14 Nov 2017
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA advisory about deadly risks associated with Kratom
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Nov 2017
Theravance Biopharma and Mylan Submit New Drug Application to FDA for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Nov 2017
EMD Serono Receives FDA Approval for New GONAL-f(R) RFF Redi-ject(R) Pen
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 13 Nov 2017
Allergan Receives FDA Approval For Use of VRAYLAR(TM) (cariprazine) in the Maintenance Treatment of Schizophrenia
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 9 Nov 2017
Stryker Receives US FDA HDE Approval ror the Neuroform Atlas(TM) Stent System to Treat Wide Neck Aneurysms
Devices Interventional FDA
 HSMN NewsFeed - 8 Nov 2017
Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 6 Nov 2017
Artemis Therapeutics Receives Orphan Drug Designation From U.S. Food And Drug Administration For Artemisone For The Treatment Of Malaria
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Nov 2017
Neovasc Receives FDA Approval to Initiate Pivotal Reducer Trial
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 2 Nov 2017
Perrigo Announces Tentative FDA Approval for a First-to-File Generic Version of Picato(R) Gel 0.05%
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 1 Nov 2017
Intellijoint Surgical Inc. Receives FDA Clearance for Revision THA with intellijoint HIP(R)
Devices Orthopaedic FDA
 HSMN NewsFeed - 1 Nov 2017
IntraFuse Receives FDA 510(k) Clearance for FlexThread(TM) Fibula Pin System
Devices Orthopaedic FDA
 HSMN NewsFeed - 31 Oct 2017
BRH Medical Receives FDA Clearance for its Patented BRH-A2 Combined Ultrasound and Electric Field Stimulation Device
Devices Wound Care FDA
 HSMN NewsFeed - 31 Oct 2017
Abbott Announces FDA Clearance for its Alinity(TM) ci-series Next-generation Diagnostic Systems
Diagnostics FDA
 HSMN NewsFeed - 31 Oct 2017
Mitosol(R)'s Orphan Drug Designation is Expanded for All Glaucoma Surgery
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 30 Oct 2017
FDA Approves New 10 mg Dosing for XARELTO(R) (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE)
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Oct 2017
AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Oct 2017
Nitiloop Announces FDA 510(k) Clearance for its Nova Cross Extreme and Nova Cross BTK Micro catheter for Support of Guidewire Access to Discrete Regions of the Coronary and Peripheral Vasculature
Devices Interventional FDA
 HSMN NewsFeed - 26 Oct 2017
FDA Grants Breakthrough Therapy Designation for BioMarin's Valoctocogene Roxaparvovec (formerly BMN 270), an Investigational Gene Therapy for Hemophilia A
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Oct 2017
Acutus Medical(R) Receives FDA Clearance for Advanced Cardiac Mapping Technology for Complex Arrhythmias
Devices Cardiology FDA
 HSMN NewsFeed - 23 Oct 2017
Abbott Launches the First and Only Smartphone Compatible Insertable Cardiac Monitor in the U.S.
Devices Monitoring Cardiology FDA Product Launch
 HSMN NewsFeed - 23 Oct 2017
United Therapeutics Announces FDA Approval of Third Generation Nebulizer for the Tyvaso(R) Inhalation System
Biopharmaceuticals Drug Delivery FDA
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