Healthcare Sales & Marketing Network: FDA News Roundup

Healthcare News Roundup: FDA

HSMN NewsFeed - 21 Aug 2018
FDA Approves New FemTech Device to Enhance Quality of Care for the Uterus
Devices Urology FDA

HSMN NewsFeed - 21 Aug 2018
Audentes Announces Regenerative Medicine Advanced Therapy (RMAT) Designation Granted by the FDA to AT132 for the Treatment of X-Linked Myotubular Myopathy
Biopharmaceuticals Regenerative Medicine FDA

HSMN NewsFeed - 20 Aug 2018
Q BioMed Inc. Announces FDA Filing for Strontium Chloride Sr89 Injection USP for Relief of Metastatic Cancer Bone Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Aug 2018
FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder
Devices Neurology FDA

HSMN NewsFeed - 17 Aug 2018
Eisai And Merck Announce FDA Approval Of LENVIMA(R) (lenvatinib) Capsules For First-Line Treatment Of Unresectable Hepatocellular Carcinoma (HCC)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Aug 2018
FDA Approves EYLEA(R) (aflibercept) Injection sBLA in Wet Age-related Macular Degeneration
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 16 Aug 2018
Rafael Pharmaceuticals Receives FDA Orphan Drug Designation of CPI-613 for the Treatment of Peripheral T-Cell Lymphoma (PTCL)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Aug 2018
Grifols Achieves Key Milestone with FDA Approval of the New Consolidated Manufacturing Facility (CMF) for Production of Recombinant Proteins
Biopharmaceuticals Diagnostics FDA

HSMN NewsFeed - 15 Aug 2018
Endo Lifts Temporary Stay of FDA Litigation Following the Launch of a Bulk-Compounded Vasopressin Product by a Section 503B Outsourcing Facility
Biopharmaceuticals Generics FDA Litigation

HSMN NewsFeed - 14 Aug 2018
Inova Diagnostics Receives FDA Clearance for Test to Detect Antibodies to HMGCR
Diagnostics FDA

HSMN NewsFeed - 13 Aug 2018
US Food And Drug Administration (FDA) Clears Natural Cycles As The First Digital Method Of Birth Control In The United States
Devices Diagnostics FDA Product Launch

HSMN NewsFeed - 13 Aug 2018
7D Surgical Receives FDA Approval For Cranial Surgery
Devices Neurosurgery Surgery FDA

HSMN NewsFeed - 13 Aug 2018
Regeneron Provides Regulatory Update on EYLEA(R) (aflibercept) Injection sBLA in Wet Age-Related Macular Degeneration
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 9 Aug 2018
Athenex Pharmaceutical Division Receives FDA Clearance to Import Potassium Chloride Injection Concentrate to Address U.S. Drug Shortage
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Aug 2018
US Food and Drug Administration Approves ARAKODA(TM) (tafenoquine) tablets for oral use; First preventative antimalarial approved in almost two decades
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Aug 2018
A First in the World of Radiology: Aidoc Receives FDA Clearance to Enable Radiologists to Triage Patients Using AI
Devices Radiology FDA

HSMN NewsFeed - 8 Aug 2018
Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX(R) (daratumumab) Split Dosing Regimen
Biopharmaceuticals Oncology FDA Regulatory

HSMN NewsFeed - 7 Aug 2018
Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVI(TM) in combination with MEKTOVI(R) and cetuximab for BRAFV600E-mutant Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 6 Aug 2018
Pliant Therapeutics Receives FDA Orphan Drug Designation for Lead Program PLN-74809 in Idiopathic Pulmonary Fibrosis
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Aug 2018
Sensus Healthcare Receives FDA 501(k) Clearance to Market Next-Generation SRT-100+ Superficial Radiation Therapy for Treating Non-Melanoma Skin Cancer and Keloids
Devices Dermatology FDA Product Launch

HSMN NewsFeed - 2 Aug 2018
Abbott Expands its Directional Deep Brain Stimulation Therapy by Offering New MR-Conditional Labeling
Devices Neurology FDA

HSMN NewsFeed - 1 Aug 2018
FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 26 Jul 2018
CarboFix's CarboClear(R), Carbon Fiber Pedicle Screw System Has Been Cleared to Be Used in the United States by the FDA
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 26 Jul 2018
Flashback Technologies Announces U.S. FDA Clearance For The CipherOx(R) CRI M1 Compensatory Reserve Index (CRI(TM)) Monitor To Accurately Detect And Trend Acute Blood Loss
Devices Monitoring FDA

HSMN NewsFeed - 26 Jul 2018
Cepheid Receives FDA Clearance and CLIA Waiver for Xpert(R) Xpress Flu/RSV Test
Diagnostics FDA Product Launch

HSMN NewsFeed - 25 Jul 2018
A Big Win for Digital Health: U.S. FDA Grants Landmark Class II Approval for Clinical Grade Smartphone Testing - Healthy.io�s Dip.io Urinalysis
Devices Diagnostics FDA

HSMN NewsFeed - 24 Jul 2018
AbbVie Receives U.S. FDA Approval of ORILISSA(TM) (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
Biopharmaceuticals FDA Product Launch

HSMN NewsFeed - 24 Jul 2018
Biohaven Receives FDA May Proceed Letter And Initiates Phase 2/3 Clinical Trial Of Trigriluzole (BHV-4157) In Alzheimer's Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 23 Jul 2018
MEDICALgorithmics, Medi-Lynx Receive FDA 510(K) Clearance for PocketECG CRS Mobile Cardiac Rehabilitation System
Devices Monitoring Cardiology FDA

HSMN NewsFeed - 23 Jul 2018
Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD)
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Jul 2018
Amneal Announces FDA Approval and Launch of Generic Potassium Chloride Oral Solution
Biopharmaceuticals Generics FDA Product Launch

HSMN NewsFeed - 20 Jul 2018
FDA Grants Approval of TIBSOVO(R), the First Oral, Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jul 2018
BioPharmX Announces FDA Grant of CARC Waiver and Post-Hoc Analysis for BPX-01
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 18 Jul 2018
PainReform Gets FDA Approval for Phase III Post-Operative Pain Relief Study
Biopharmaceuticals Surgery FDA

HSMN NewsFeed - 17 Jul 2018
Candela Announces FDA Clearance Of Vbeam(R) Prima
Devices Dermatology FDA

HSMN NewsFeed - 17 Jul 2018
BAROnova Announces Submission of Premarket Approval (PMA) Application to the U.S. FDA for the TransPyloric Shuttle(R) (TPS(R)) Device Intended for the Treatment of Obesity
Devices FDA

HSMN NewsFeed - 16 Jul 2018
Stryker receives US FDA Pre-market approval for the Surpass Streamline(TM) Flow Diverter to treat large and giant unruptured aneurysms
Devices Interventional Neurology Radiology FDA

HSMN NewsFeed - 13 Jul 2018
Amgen And UCB Resubmit Biologics License Application (BLA) For EVENITY(TM) (romosozumab) To The US FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Jul 2018
Gala Therapeutics Receives FDA IDE Approval for a US Early Feasibility Study of Its RheOx(TM) System to Treat Chronic Bronchitis
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Jul 2018
FDA Accepts Biologics License Application For Subcutaneous Formulation Of Herceptin
Biopharmaceuticals Drug Delivery Oncology FDA

HSMN NewsFeed - 9 Jul 2018
Oculocare's Alleye(R) Receives FDA 510(k) Clearance for Monitoring Eyesight in AMD
Devices Diagnostics Ophthalmology FDA

HSMN NewsFeed - 9 Jul 2018
Companion Medical Announces FDA Clearance for the InPen System for Android
Devices Endocrinology FDA

HSMN NewsFeed - 9 Jul 2018
OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 6 Jul 2018
FDA Clears The Way: Lipogems' Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body's Own Fat To Support Tissue Repair In Orthopaedic And Arthroscopic Surgeries
Regenerative Medicine Orthopaedic FDA

HSMN NewsFeed - 4 Jul 2018
Theratechnologies Submits Novel Single-Vial Formulation of EGRIFTA(R) (Tesamorelin for Injection) for FDA Approval
Biopharmaceuticals HIV/AIDS FDA

HSMN NewsFeed - 28 Jun 2018
Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology(TM) Hyperlordotic ALIF Interbody Spinal Fusion System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 27 Jun 2018
Revive Therapeutics Announces FDA Grants Orphan Drug Designation for Cannabidiol in the Treatment of Autoimmune Hepatitis
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Jun 2018
Beckman Coulter Diagnostics Receives U.S. FDA 510(k) Clearance for High- sensitivity Access hsTnI Assay
Diagnostics Cardiology FDA

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