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Healthcare News Roundup: 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 - 12 Oct 2018
Rockwell Medical Provides Update on IV Triferic
Biopharmaceuticals 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
Perrigo Confirms Patent Challenge for Generic Version of Jublia(R) Topical Solution 10%
Biopharmaceuticals Generics FDA Litigation
 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
Epilepsy Foundation Statement on DEA's Scheduling of Epidiolex(R)
Biopharmaceuticals Neurology 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 - 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
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