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Healthcare News Roundup: FDA

 HSMN NewsFeed - 14 Jul 2020
FDA Grants the Doraya AHF Catheter Breakthrough Designation
Devices Cardiology FDA
 HSMN NewsFeed - 14 Jul 2020
GI Supply Gets FDA Clearance of First Submucosal Lifting Agent in a Pre-filled 5mL Syringe
Devices Gastroenterology FDA
 HSMN NewsFeed - 14 Jul 2020
TREMFYA(R) (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Jul 2020
World's First FDA IDE Coronary Patient Treated With a DEB
Devices Interventional Cardiology
 HSMN NewsFeed - 6 Jul 2020
Cochlear obtains FDA approval of Kanso 2 Sound Processor, first off-the-ear cochlear implant sound processor with direct smartphone connectivity
Devices FDA
 HSMN NewsFeed - 6 Jul 2020
Abbott Receives FDA Approval for New Heart Rhythm Devices Featuring Bluetooth Connectivity and Continuous Remote Monitoring
Devices Cardiology FDA
 HSMN NewsFeed - 6 Jul 2020
BD Launches Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15 minutes, Dramatically Expanding Access to COVID-19 Testing
Diagnostics FDA Product Launch
 HSMN NewsFeed - 1 Jul 2020
Engage Surgical Announces FDA 510(k) Clearance And Limited Market Release Of The Cementless Engage(TM) Partial Knee System
Devices Orthopaedic FDA
 HSMN NewsFeed - 1 Jul 2020
Carag Receives U.S. FDA IDE Approval to Conduct Clinical Study of First Transcatheter Septal Occluder With Bioresorbable, Metal-free Framework
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 29 Jun 2020
Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx(TM) Insertable Cardiac Monitor System
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 29 Jun 2020
SFA Therapeutics Announces FDA Approval To Begin IND Trial
Biopharmaceuticals Dermatology
 HSMN NewsFeed - 26 Jun 2020
Citius Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Jun 2020
Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Jun 2020
Preceptis Medical announces the Hummingbird(R) device has received FDA 510(k) clearance for ear tube placement in young children in the ENT's office without general anesthesia
Devices FDA
 HSMN NewsFeed - 22 Jun 2020
FDA Accepts Supplemental Biologics License Application (sBLA) for BOTOX(R) (onabotulinumtoxinA) for the Treatment of Pediatric Patients with Neurogenic Detrusor Overactivity
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 22 Jun 2020
Cipla Launches CIPREMI (remdesivir Lyophilised Powder for Injection 100 mg), the Only U.S. FDA Approved Emergency Use Authorisation (EUA) Treatment for Patients With Severe COVID-19 Disease
Biopharmaceuticals Product Launch
 HSMN NewsFeed - 18 Jun 2020
Almirall Announces FDA Approval Of Updated Label For Seysara(R) (Sarecycline) Tablets
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 15 Jun 2020
Abbott's FreeStyle(R) Libre 2 iCGM Cleared in U.S. for Adults and Children with Diabetes, Achieving Highest Level of Accuracy and Performance Standards
Devices Monitoring Endocrinology FDA
 HSMN NewsFeed - 11 Jun 2020
CNS Announces the FDA has Granted Orphan Drug Designation for Brain Cancer Drug Berubicin
Biopharmaceuticals Oncology Neurology FDA
 HSMN NewsFeed - 11 Jun 2020
Lannett Provides Update On Clinical Advancement Of Biosimilar Insulin Glargine, Following FDA Meeting
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 Jun 2020
FDA Issues Emergency Use Authorization for ChromaCode's High-Throughput HDPCR(TM) SARS-CoV-2 Real-Time PCR Assay
Diagnostics FDA
 HSMN NewsFeed - 10 Jun 2020
F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever) and FDA QIDP Designation for Multiple Fungal Infections
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Jun 2020
FDA Grants EUA to Rapid COVID-19 Antibody Testing Product Distributed by Premier Biotech
Diagnostics FDA
 HSMN NewsFeed - 9 Jun 2020
BioMedInnovations LLC Announces U.S. Food and Drug Administration Has Granted Emergency Use Authorization to Manufacture and Distribute SuppleVent(TM), a Unique and Value-Added Ventilator Technology
Devices FDA
 HSMN NewsFeed - 8 Jun 2020
Insmed Receives FDA Breakthrough Therapy Designation for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFBE)
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Jun 2020
FDA Clears Innovative Angioplasty Scoring and Cutting Platform
Devices Interventional FDA
 HSMN NewsFeed - 2 Jun 2020
FDA Clears IND for iNKT Cells to Treat COVID-19 Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Jun 2020
Rhaeos, Inc. Receives FDA Breakthrough Device Designation for FlowSense(TM) Noninvasive Thermal Sensor
Devices Monitoring Neurosurgery FDA
 HSMN NewsFeed - 1 Jun 2020
Lilly's Taltz(R) (ixekizumab) is the First IL-17A Antagonist to Receive U.S. FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 May 2020
Cardiff Oncology Announces Fast Track Designation Granted by the FDA to Onvansertib for Second-Line Treatment of KRAS-Mutated Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 May 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Submission of Biologics License Application to U.S. Food and Drug Administration for Pegunigalsidase Alfa for the Treatment of Fabry Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 May 2020
SMART Medical Systems Receives FDA Clearance for Its G-EYE(R) Colonoscope
Devices Gastroenterology Oncology FDA
 HSMN NewsFeed - 25 May 2020
4DMedical's Lung Imaging Technology Receives FDA Clearance as COVID-19 Intensifies Global Focus on Respiratory Health
Diagnostics Radiology FDA
 HSMN NewsFeed - 22 May 2020
Hikma receives FDA approval for its generic Vascepa(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 21 May 2020
Cipla Receives Final Approval for Generic Version of Migranal(R) (Dihydroergotamine Mesylate Nasal Spray 4mg/mL) With a Competitive Generic Therapy Designation
Biopharmaceuticals Generics FDA Product Launch
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