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Healthcare News Roundup: 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
 HSMN NewsFeed - 19 May 2020
ArcherDX Receives Breakthrough Device Designation to Detect NTRK Gene Fusions
Diagnostics Oncology FDA
 HSMN NewsFeed - 19 May 2020
Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States
Diagnostics Oncology FDA
 HSMN NewsFeed - 15 May 2020
Blueprint Medicines Receives Complete Response Letter from FDA for Avapritinib New Drug Application for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 May 2020
Olympic Ophthalmics Receives FDA Clearance for iTEAR100(R) Neurostimulator
Devices Ophthalmology FDA
 HSMN NewsFeed - 13 May 2020
Arbor Pharmaceuticals Announces FDA Filing Acceptance of New Drug Application (NDA) for AR19, an Investigational ADHD Prescription Stimulant Treatment Specifically Designed to Resist Physical Manipulation for Nonmedical Misuse or Abuse
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 May 2020
Optina Diagnostics receives 510(k) clearance from U.S. FDA for its MHRC-C1, permitting hyperspectral imaging of the retina
Devices Ophthalmology FDA
 HSMN NewsFeed - 13 May 2020
Vanda Pharmaceuticals Announces Agreement with FDA on Resubmission of the Application for HETLIOZ(R) for the Treatment of Patients with Smith-Magenis Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 May 2020
FDA Clears New XO Cross Microcatheter Platform
Devices Interventional FDA
 HSMN NewsFeed - 11 May 2020
Abbott Receives FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity(TM) i System
Diagnostics FDA Product Launch
 HSMN NewsFeed - 8 May 2020
FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 7 May 2020
Camber Spine Technologies Announces Nationwide Launch Of SPIRA(R)-C Integrated And FORTICO Anterior Cervical Plate
Devices Orthopaedic Neurosurgery FDA Product Launch
 HSMN NewsFeed - 7 May 2020
OPTI Medical Systems Receives US FDA Emergency Use Authorization for Its OPTI SARS-CoV-2 RNA PCR Test Kit for Detection of the Virus Causing COVID-19
Diagnostics FDA
 HSMN NewsFeed - 6 May 2020
FDA Clears New Mechanical Thrombectomy Platform
Devices Interventional FDA
 HSMN NewsFeed - 5 May 2020
Galderma Receives FDA Approval For Restylane(R) Kysse, A New Hyaluronic Acid (HA) Filler Specifically Designed And Indicated To Add Fullness To The Lips And Help Smooth The Wrinkles Above The Mouth
Devices Dermatology FDA
 HSMN NewsFeed - 4 May 2020
FDA Approves FENSOLVI(R) (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 May 2020
FX Solutions, SAS. [FX Shoulder, Inc.] Receives FDA 510k Clearances for Humeral Cup Stability & Humeral Cup 135/145° Stability
Devices Orthopaedic FDA
 HSMN NewsFeed - 1 May 2020
SciBase Receives FDA Approval for Nevisense 3.0
Devices Dermatology Oncology FDA
 HSMN NewsFeed - 30 Apr 2020
Alpha Cognition, Inc. Receives FDA/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 29 Apr 2020
ANI Receives Refusal to File Letter from FDA for Cortrophin(R) Gel
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Apr 2020
Bimini Health Tech Announces FDA 510(k) Clearance for Dermapose Access Office-Based Fat Harvesting System
Devices Dermatology FDA
 HSMN NewsFeed - 27 Apr 2020
Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS(R) (opicapone) as an Add-On Treatment for Patients with Parkinson's Disease Experiencing "Off" Episodes
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 23 Apr 2020
VisCardia Announces Its Novel Heart Failure Therapy Receives Breakthrough Device Designation From the FDA
Devices Cardiology FDA
 HSMN NewsFeed - 22 Apr 2020
Bimini Health Tech Announces FDA 510(k) Clearance for Dermapose Refresh Fat Transfer Technology
Devices Dermatology FDA Product Launch
 HSMN NewsFeed - 22 Apr 2020
Novartis Kymriah(R) receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma
Biopharmaceuticals Regenerative Medicine Oncology FDA
 HSMN NewsFeed - 16 Apr 2020
Provention Bio Initiates Rolling Submission of Biologic License Application for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals
Biopharmaceuticals FDA
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