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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 - 9 Nov 2018
FDA authorizes emergency use of first Ebola fingerstick test with portable reader
Diagnostics FDA
 HSMN NewsFeed - 7 Nov 2018
HemoScreen(TM) Hematology Analyzer for Point of Care, Receives FDA 510(k) Clearance
Devices Diagnostics FDA
 HSMN NewsFeed - 6 Nov 2018
FDA Approves Ortho Clinical Diagnostics VITROS(R) Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on the VITROS(R) 5600 Integrated System
Diagnostics HIV/AIDS FDA
 HSMN NewsFeed - 5 Nov 2018
Galderma Announces FDA Approval of Restylane(R) Lyft For Midface Injection via Cannula
Devices Dermatology FDA
 HSMN NewsFeed - 5 Nov 2018
Shoulder Innovations Announces FDA 510(k) Clearance For Shoulder Technology
Devices Orthopaedic FDA
 HSMN NewsFeed - 1 Nov 2018
OsteoRemedies(R) Announces the First FDA Cleared Dual-Antibiotic Spacer and Bone Cement with Gentamicin and Vancomycin
Devices Orthopaedic FDA Product Launch
 HSMN NewsFeed - 30 Oct 2018
U.S. FDA Approves INVOKANA(R) (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
Biopharmaceuticals Endocrinology Cardiology FDA
 HSMN NewsFeed - 24 Oct 2018
FDA Approves New SynchroMed(TM) II myPTM(TM) Personal Therapy Manager That Enables Patients to Alleviate Unpredictable Pain
Devices Drug Delivery Neurology FDA
 HSMN NewsFeed - 24 Oct 2018
Inova Diagnostics Launches First FDA Cleared Calprotectin Extraction Device
Devices Diagnostics FDA Product Launch
 HSMN NewsFeed - 24 Oct 2018
Anixa Biosciences Announces Scheduling of Pre-Sub Meeting with FDA for its Cchek(TM) Cancer Diagnostic Test
Diagnostics Oncology FDA
 HSMN NewsFeed - 23 Oct 2018
Monteris(R) Medical Announces FDA Clearance of Laser Probe with Fiber Optic Controlled Cooling for Use with the NeuroBlate(R) System
Devices Neurosurgery FDA
 HSMN NewsFeed - 23 Oct 2018
COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 23 Oct 2018
Duchesnay Inc. Announces Submission of Supplemental New Drug Application (sNDA) for Osphena(R) (ospemifene) to U.S. FDA Seeking Approval for the Treatment of Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy (VVA) Due to Menopause
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Oct 2018
Eiger BioPharmaceuticals Receives FDA Rare Pediatric Disease (RPD) Designation for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies and Plans NDA Filing in 2019
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Oct 2018
FDA Approves Asthma Indication for Dupixent(R) (dupilumab)
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Oct 2018
Abbott's HeartMate 3 Heart Pump Now FDA Approved for Advanced Heart Failure Patients Not Eligible for a Heart Transplant
Devices Cardiology FDA
 HSMN NewsFeed - 17 Oct 2018
AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA(R) (ibrutinib) in Combination with Obinutuzumab (GAZYVA(R)) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Oct 2018
FDA Approves Medicines360's sNDA for LILETTA(R) (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 15 Oct 2018
CIVCO Radiotherapy Announces FDA 510k Clearance and CE Mark of their Solstice SRS Immobilization System
Devices Oncology FDA Regulatory
 HSMN NewsFeed - 12 Oct 2018
FDA Approves Grifols ID CORE XT Test For Molecular Red Blood Cell Typing
Diagnostics FDA
 HSMN NewsFeed - 11 Oct 2018
Transseptal Solutions Announces FDA Clearance of Its Novel Transseptal Access System for Transseptal Puncture and Left Atrial Navigation
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 11 Oct 2018
FDA Approves Stiolto(R) Respimat(R) Supplemental New Drug Application (sNDA) to Add Data on COPD Exacerbation Reduction
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 10 Oct 2018
SpineEX(R) Announces FDA Clearance of Sagittae(R) Lateral Lumbar Interbody Fusion Devices
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 9 Oct 2018
Lixte Biotechnology Files an IND with the FDA to Conduct a Phase 1b/2 Trial of LB-100 in Patients with Myelodysplastic Syndrome at Moffitt Cancer Center
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Oct 2018
Bausch Health's BRYHALI(TM) (halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 8 Oct 2018
U.S. FDA Announces Joint Advisory Committee Review of Mallinckrodt's Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone(R) (Oxycodone Hydrochloride)
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 5 Oct 2018
ZEISS Receives FDA Approval for ReLEx SMILE, Expanding Myopia Treatment to Patients with Astigmatism
Devices Ophthalmology FDA
 HSMN NewsFeed - 4 Oct 2018
Allergan Receives FDA Clearance To Treat Area Below The Jawline With CoolSculpting(R)
Devices Dermatology FDA
 HSMN NewsFeed - 2 Oct 2018
Processa Pharmaceuticals Receives FDA Clearance Of IND To Begin Phase 2 Clinical Development Of PCS-499 In Necrobiosis Lipoidica Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Oct 2018
FDA Approves KYPROLIS(R) (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone (Kd70) For Patients With Relapsed Or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Sep 2018
FDA Grants Profounda Inc. Competitive Generic Therapy (CGT) Designation for planned ANDA filing of Minocycline Hydrochloride Microspheres,1 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 26 Sep 2018
INSIGHTEC Receives FDA Approval for Exablate Neuro Compatibility With Siemens Healthineers MRI Scanners
Devices Neurology Radiology FDA
 HSMN NewsFeed - 26 Sep 2018
Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology 3D-Printed Lateral Interbody Fusion System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 26 Sep 2018
Aronora's New Blood Clot Treatment Receives FDA Fast Track Designation
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Sep 2018
Neurelis Files New Drug Application with the FDA for VALTOCO(TM) Nasal Spray, an Investigational Treatment for Pediatric, Adolescent and Adult Epilepsy Patients
Biopharmaceuticals Neurology Drug Delivery FDA
 HSMN NewsFeed - 24 Sep 2018
Boston Scientific Receives U.S. FDA Approval for the Eluvia(TM) Drug-Eluting Vascular Stent System
Devices Interventional FDA
 HSMN NewsFeed - 20 Sep 2018
FDA Clears Augmented Reality Visualization Solution GLOW800
Devices Neurosurgery FDA
 HSMN NewsFeed - 19 Sep 2018
OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 17 Sep 2018
Anti-migraine Head Patch - HeadaTerm - Receives FDA Clearance
Devices Neurology FDA
 HSMN NewsFeed - 17 Sep 2018
U.S. FDA Clears Sebacia Microparticles for the Treatment of Mild to Moderate Inflammatory Acne
Devices Dermatology FDA
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