Healthcare Sales & Marketing Network: FDA : Medical Device and Pharmaceutical News

Healthcare News Roundup: FDA

HSMN NewsFeed - 3 May 2017
Luminex Corporation Receives FDA Clearance for ARIES Bordetella Assay
Diagnostics FDA

HSMN NewsFeed - 3 May 2017
Soligenix Receives FDA Protocol Clearance of Pivotal Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 May 2017
Medtronic Launches Resolute Onyx(TM) Drug-Eluting Stent in United States Following FDA Approval Becoming First DES Available in 4.5 mm and 5 mm Sizes
Devices Interventional Cardiology FDA Product Launch

HSMN NewsFeed - 1 May 2017
FDA Clears Roche High-Volume Immunoassay Lab Testing Solution to Support Critical Medical Treatment Decisions
Diagnostics FDA

HSMN NewsFeed - 28 Apr 2017
Invivoscribe(R) Receives FDA Approval for the LeukoStrat(R) CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt(R) and is the First Companion Diagnostic for AML
Diagnostics Personalized Medicine Oncology FDA

HSMN NewsFeed - 28 Apr 2017
Novartis Receives FDA Approval for Rydapt(R) in Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) and Three Types of Systemic Mastocytosis (SM)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Apr 2017
FDA Approves Radius Health’s TYMLOS(TM) (abaloparatide), a Bone Building Agent for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Apr 2017
Venus Medtech's TAVR Device Is Approved By CFDA, Creating A New Era Of Interventional Cardiology In China
Devices Interventional Cardiology Regulatory

HSMN NewsFeed - 28 Apr 2017
Regeneron and Sanofi Announce Kevzara(R) (sarilumab) Biologics License Application Resubmission Accepted for Review by U.S. FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Apr 2017
Tepha Inc. Subsidiary, Galatea Surgical, Announces the Launch of GalaFORM(TM) 3D Surgical Scaffold
Devices Surgery FDA Product Launch

HSMN NewsFeed - 26 Apr 2017
Impax Announces FDA Approval and Launch of a Generic Version of Vytorin(R) (Ezetimibe/Simvastatin Tablets)
Biopharmaceuticals Generics FDA Product Launch

HSMN NewsFeed - 26 Apr 2017
FDA Approves XATMEP(TM), the First and Only Ready-To-Use Methotrexate Oral Solution
Biopharmaceuticals FDA

HSMN NewsFeed - 26 Apr 2017
Inspirion Delivery Sciences Receives FDA Approval for RoxyBond(TM) (oxycodone hydrochloride) tablets CII, the First and Only Immediate Release Opioid Analgesic with Abuse-Deterrent Label Claims
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 26 Apr 2017
Bausch & Lomb Receives 510(k) Clearance From FDA For Vitesse(TM), The First And Only Hypersonic, Open-Port Vitrectomy System
Devices Ophthalmology FDA

HSMN NewsFeed - 25 Apr 2017
FDA Takes Action Against 14 Companies for Selling Illegal Cancer Treatments
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Apr 2017
Sanofi and Regeneron Announce FDA Approval of a New Once-Monthly Dosing Option for Praluent(R) (alirocumab) Injection
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 25 Apr 2017
Epygenix Therapeutics Receives Orphan Drug Designation From the U.S. FDA for EPX-100 and EPX-200 in the Treatment of Patients With Dravet Syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 24 Apr 2017
Millennium Medical Technologies (MMT) First in the Nation to Receive FDA Clearance for a Reusable Fat Collection and Grafting System
Devices Surgery FDA

HSMN NewsFeed - 20 Apr 2017
FDA Clears Halyard Health's COOLIEF for the Management of Osteoarthritis Knee Pain
Devices Orthopaedic FDA

HSMN NewsFeed - 19 Apr 2017
Ethicon Announces 510(k) Clearance For ECHELON CIRCULAR(TM) Powered Stapler
Devices Surgery FDA

HSMN NewsFeed - 19 Apr 2017
Edwards' Advanced Hemodynamic Monitoring Platform Receives FDA Clearance
Devices Cardiology Monitoring FDA

HSMN NewsFeed - 19 Apr 2017
CytRx Announces FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in Soft Tissue Sarcomas
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Apr 2017
FDA Releases gammaCore(R), the First Non-Invasive Vagus Nerve Stimulation Therapy Applied at the Neck for Acute Treatment of Pain Associated with Episodic Cluster Headache in Adult Patients
Devices FDA

HSMN NewsFeed - 18 Apr 2017
Monitored Therapeutics, Inc. Receives FDA Clearance for First Full Home-Use Spirometer With Wireless Connection
Devices FDA

HSMN NewsFeed - 18 Apr 2017
Novartis CAR-T cell therapy CTL019 receives FDA Breakthrough Therapy designation for treatment of adult patients with r/r DLBCL
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Apr 2017
Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP
Biopharmaceuticals

HSMN NewsFeed - 17 Apr 2017
AMAG Submits Supplemental New Drug Application to FDA for Makena(R) (Hydroxyprogesterone Caproate Injection) Auto-Injector for Subcutaneous Use
Biopharmaceuticals Devices Drug Delivery FDA

HSMN NewsFeed - 17 Apr 2017
Ivaoes Animal Health Launches New Anesthetic Product, Rapanofal(TM) (Propofol Emulsion Injection), the only FDA-approved Propofol Product Formulation Indicated for Use in Cats and Dogs
Biopharmaceuticals Product Launch

HSMN NewsFeed - 14 Apr 2017
U.S. FDA Issues Complete Response Letter for Baricitinib
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Apr 2017
Additive Orthopaedics Announces FDA Clearance of their Locking Lattice Plating System for the Global Extremities Market
Devices Orthopaedic FDA

HSMN NewsFeed - 13 Apr 2017
Philips receives FDA clearance to market Philips IntelliSite Pathology Solution for primary diagnostic use in the U.S.
Diagnostics FDA

HSMN NewsFeed - 12 Apr 2017
Biotricity Files for its Second and Final FDA 510(k) to Bring Bioflux Solution to Market
Devices Monitoring Cardiology FDA

HSMN NewsFeed - 12 Apr 2017
Cxbladder Monitor Significantly Outperforms All Compared FDA Approved Urine Tests For Bladder Cancer; Enhancing The Standard Of Care For Bladder Cancer Patients
Diagnostics Urology Oncology

HSMN NewsFeed - 7 Apr 2017
FDA Approves Two Hepatitis C Drugs for Pediatric Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Apr 2017
Supernus Receives Final FDA Approval for Trokendi XR(R) for Migraine Prophylaxis in Adults and Adolescents
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Apr 2017
Teva Announces FDA Approval of AUSTEDO(TM) (deutetrabenazine) Tablets for the Treatment of Chorea Associated with Huntington’s Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 30 Mar 2017
U.S. FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's HUMIRA(R) (adalimumab) Prescribing Information
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Mar 2017
Sonoma Pharmaceuticals Receives U.S. FDA Clearance of Loyon(R) Skin Descaler for Relief of Scaling Associated with Various Dermatoses
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 29 Mar 2017
FDA Approves Genentech’s OCREVUS(TM) (Ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 28 Mar 2017
Sanofi and Regeneron Announce FDA Approval of Dupixent(R) (dupilumab), the First Targeted Biologic Therapy for Adults with Moderate-to-Severe Atopic Dermatitis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 27 Mar 2017
Bovie Medical Receives 510K Clearance for Its Cool-Coag(TM) Generator and Open Handpiece
Devices Surgery FDA

HSMN NewsFeed - 24 Mar 2017
FDA Grants Approval for BAVENCIO(R) (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology FDA Product Launch

HSMN NewsFeed - 22 Mar 2017
Moleculin Receives Orphan Drug Designation for Annamycin for the Treatment of Acute Myeloid Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Mar 2017
BioStable Science & Engineering Announces FDA Clearance of the HAART(TM) 300 Aortic Annuloplasty Device
Devices Cardiology FDA

HSMN NewsFeed - 22 Mar 2017
Allergan Announces Availability of RESTASIS MULTIDOSE(TM) (Cyclosporine Ophthalmic Emulsion) 0.05% -- the First FDA-Approved Preservative Free Prescription Eye Drop Available in a Multidose Bottle
Biopharmaceuticals Ophthalmology Product Launch

HSMN NewsFeed - 21 Mar 2017
Pain Therapeutics Announces Positive Regulatory Guidance for REMOXY(TM) ER
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 20 Mar 2017
Trovita Health Science Announces FDA Marketing Clearance of New SAFE-T FEED(TM) Nutrition Delivery Device for Tube Feeding
Devices FDA

HSMN NewsFeed - 20 Mar 2017
JUVÉDERM VOLLURE(TM) XC Approved by U.S. FDA for Correction of Facial Wrinkles and Folds in Adults over the Age of 21
Devices Dermatology FDA

HSMN NewsFeed - 17 Mar 2017
Toshiba Medical’s New Premium Cardiovascular Ultrasound Receives FDA Clearance
Devices Cardiology FDA

HSMN NewsFeed - 15 Mar 2017
DJO Global Announces FDA 510(k) Clearance for Exprt(R) Revision Hip
Devices Orthopaedic FDA

HSMN NewsFeed - 15 Mar 2017
FDA Approves Merck’s KEYTRUDA(R) (pembrolizumab) for Adult and Pediatric Patients with Classical Hodgkin Lymphoma (cHL) Refractory to Treatment, or Who Have Relapsed After Three or More Prior Lines of Therapy
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Mar 2017
Teleflex (TFX) Announces 510(k) Clearance and Global Launch of Twin-Pass(R) Torque Dual Access Catheter
Devices Interventional Cardiology FDA Product Launch

HSMN NewsFeed - 14 Mar 2017
Teleflex (TFX) Announces 510(k) Clearance and U.S. Launch of Spectre(TM) Guidewire
Devices Interventional Cardiology FDA Product Launch

HSMN NewsFeed - 13 Mar 2017
Spineology(R) Announces Expanded FDA Clearance of Elite(TM) Expandable Interbody Fusion System
Devices Orthopaedic Neurosurgery FDA

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