Healthcare Sales & Marketing Network News: FDA

Healthcare News Roundup: FDA

HSMN NewsFeed - 18 Nov 2019
Levo Therapeutics Receives Fast Track Designation From FDA for Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome
Biopharmaceuticals Neurology Drug Delivery FDA

HSMN NewsFeed - 18 Nov 2019
Protalix BioTherapeutics and Chiesi Farmaceutici Announce Successful pre-BLA Meeting with FDA for Accelerated Approval of pegunigalsidase alfa for the Treatment of Fabry Disease in the United States
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Nov 2019
Ultromics Receives FDA Clearance for its AI-powered Decision Support System, EchoGo Core
Devices Cardiology FDA

HSMN NewsFeed - 11 Nov 2019
Allergan Receives FDA Qualified Infectious Disease Product (QIDP) Designation And Fast Track Designation For ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Nov 2019
AI Medical Service Inc. announces FDA Breakthrough Device Designation for endoscopic AI system
Devices Gastroenterology FDA

HSMN NewsFeed - 11 Nov 2019
Lipocine Receives Complete Response Letter for TLANDO(TM) from U.S. FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Nov 2019
Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA(R) (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Nov 2019
EIP Pharma Announces U.S. FDA Grants Fast-Track Designation to Neflamapimod as a Treatment for Dementia with Lewy Bodies (DLB)
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 5 Nov 2019
Nevro Announces U.S. Launch of Senza(R) Omnia(TM) Spinal Cord Stimulation System to Treat Chronic Pain
Devices Neurology FDA Product Launch

HSMN NewsFeed - 31 Oct 2019
Stryker receives FDA clearance for SAHARA(R) Lateral 3D Expandable Interbody System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 31 Oct 2019
Cytotron(R) Granted 'Breakthrough Device Designation' by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers
Devices Oncology FDA

HSMN NewsFeed - 30 Oct 2019
Biogen and Alkermes Announce FDA Approval of VUMERITY(TM) (diroximel fumarate) for Multiple Sclerosis
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 28 Oct 2019
SFA Therapeutics, Inc. Receives an FDA Orphan Drug Designation (ODD) for SFA001 in the Treatment of Hepatocellular Carcinoma (HCC)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 24 Oct 2019
Fresenius Medical Care Receives FDA Breakthrough Device Designation for New Dialysis System to Prevent Blood Clotting Without the Use of Blood Thinners
Devices FDA

HSMN NewsFeed - 24 Oct 2019
FDA Approves BOTOX(R) (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Oct 2019
Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI(R) Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Oct 2019
Nplate(R) (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Oct 2019
FDA Clears ORTHO(TM) Sera ID-MTS for Use on the ORTHO VISION(R) Analyzer
Diagnostics FDA

HSMN NewsFeed - 17 Oct 2019
CarboFix Extends Its CarboClear(R) Carbon Fiber Spinal Product Line With Its FDA Cleared Vertebral Body Replacement (VBR) System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 16 Oct 2019
Fidmi Medical Receives FDA Regulatory Clearance for Low-profile Enteral Feeding Device
Devices FDA

HSMN NewsFeed - 15 Oct 2019
BIOLASE Announces First-Ever U.S. & Canada Regulatory Clearance of Laser Crown and Veneer Removal
Devices Dental FDA Regulatory

HSMN NewsFeed - 14 Oct 2019
OssDsign Receives US FDA Clearance for Cranial PSI Accessories - Strengthening Business Position in the US
Devices Neurosurgery FDA

HSMN NewsFeed - 10 Oct 2019
FDA Clears GEKO DEVICE for Use in Non-surgical Patients at Risk for Deep Vein Thrombosis Based on Study Demonstrating a Zero Percent DVT Rate in Patients After a Stroke
Devices FDA

HSMN NewsFeed - 10 Oct 2019
FDA Grants Ofev(R) Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Oct 2019
Corvia Medical's Interatrial Shunt Device (IASD(R)) Receives Breakthrough Device Designation For Heart Failure
Devices Interventional Cardiology FDA

HSMN NewsFeed - 8 Oct 2019
Sekisui Diagnostics Announces FDA Clearance and CLIA Waiver of the Acucy(TM) Influenza A&B Test
Diagnostics FDA

HSMN NewsFeed - 7 Oct 2019
ProTom Receives U.S. FDA 510(k) Clearance for Its Radiance 330(R) Single Room Proton Therapy System
Devices Oncology FDA

HSMN NewsFeed - 2 Oct 2019
Blood Flow Monitoring Device - FlowMet-R Gets FDA 510K Clearance
Devices Monitoring FDA

HSMN NewsFeed - 2 Oct 2019
DURECT Announces FDA Advisory Committee Meeting to Review POSIMIR(R) for the Treatment of Post-Surgical Pain
Biopharmaceuticals Drug Delivery Surgery FDA

HSMN NewsFeed - 30 Sep 2019
Endo Announces Successful Culmination of Litigation Regarding FDA Compounding Policy
Biopharmaceuticals Generics FDA Litigation

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