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Healthcare News Roundup: 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 - 18 Sep 2018
1st Wireless, Handheld, FDA-approved Ultrasound Device to Offer Live Demos at FMX (Family Medicine Experience) 2018, Booth #722
Devices Product Launch
 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
 HSMN NewsFeed - 13 Sep 2018
Olympus Introduces EZ Shot 3 Plus 25 G EUS Needle with Enhanced Maneuverability for Uncompromised Access to Any Lesion, Consistent Performance to Potentially Reduce Procedural Costs and Procedure Time
Devices Oncology FDA Product Launch
 HSMN NewsFeed - 13 Sep 2018
FDA Approves CroFab(R) Product Improvements
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Sep 2018
FDA to Review EYLEA (aflibercept) Injection for the Treatment of Diabetic Retinopathy
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 13 Sep 2018
Ardelyx Submits New Drug Application for U.S. Marketing Authorization of Tenapanor for IBS-C to U.S. Food and Drug Administration
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 12 Sep 2018
Biohaven Announces Submission of IND for BHV-3500, Third-Generation, Small Molecule CGRP-Receptor Antagonist for the Treatment of Migraine
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 12 Sep 2018
FDA to Review Supplemental Biologics License Application for Praluent(R) (alirocumab)Injection as Potential Treatment to Reduce Major Adverse Cardiovascular Events
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 7 Sep 2018
Perrigo Announces Final FDA Approval and Planned Launch for the Store Brand OTC Equivalent of Imodium(R) Multi-Symptom Relief
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 6 Sep 2018
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to product/label mix-up
Biopharmaceuticals FDA Product Recall
 HSMN NewsFeed - 6 Sep 2018
Johnson & Johnson Vision Launches Next Generation of Personalized LASIK Treatment, iDESIGN Refractive Studio Now Available
Devices Ophthalmology FDA Product Launch
 HSMN NewsFeed - 5 Sep 2018
ARMGO Pharma Receives FDA Orphan Drug Designation for ARM210/S48168 for the Treatment of Ryanodine Receptor Type 1 Related Myopathies
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Sep 2018
Genoptix Launches FDA-Authorized BCR-ABL MRDx(R) TFR Monitoring Test for Patients with Chronic Myeloid Leukemia on Tasigna(R) (nilotinib)
Diagnostics Oncology Product Launch
 HSMN NewsFeed - 31 Aug 2018
FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles
Biopharmaceuticals FDA Product Recall
 HSMN NewsFeed - 27 Aug 2018
Cantex Pharmaceuticals, Inc. Receives FDA Fast Track Designation For CX-01 For The Treatment Of Patients Over Age 60 With Newly Diagnosed Acute Myeloid Leukemia (AML)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Aug 2018
AbbVie Announces IMBRUVICA(R) (ibrutinib) Plus Rituximab Approval by U.S. FDA as First Chemotherapy-Free Combination Treatment in Adults with Waldenström's Macroglobulinemia, a Rare Type of Blood Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Aug 2018
Ortho Dermatologics Receives FDA Approval For ALTRENO(TM) (tretinoin 0.05%) Lotion For Acne
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 23 Aug 2018
Dthera Sciences Receives FDA Breakthrough Device Designation For Its Alzheimer's Focused Development-Stage Product "DTHR-ALZ"
Devices Neurology FDA
 HSMN NewsFeed - 23 Aug 2018
Roche receives FDA approval for cobas EGFR Mutation Test v2 as companion diagnostic with IRESSA (gefitinib) in first-line treatment of patients with non-small cell lung cancer (NSCLC)
Diagnostics Oncology FDA
 HSMN NewsFeed - 23 Aug 2018
Mallinckrodt And NPXe Announce FDA Fast Track Designation For Phase 3 Trial Of Inhaled Xenon Gas Therapy
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Aug 2018
MagVenture, Inc: FDA Clears 3-Minute, Non-Pharmaceutical Depression Treatment
Devices Neurology 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
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