Healthcare Sales & Marketing Network: FDA : Medical Device and Pharmaceutical News

Healthcare News Roundup: 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

HSMN NewsFeed - 15 Apr 2020
FDA-Cleared Coala Heart Monitor Now Enables Virtual Heart and Lung Exams From a Patient's Home
Devices Monitoring FDA

HSMN NewsFeed - 15 Apr 2020
Synapse Biomedical Receives FDA Emergency Use Authorization for New System to Assist in Weaning Patients off of Ventilators During COVID-19 Pandemic
Devices FDA

HSMN NewsFeed - 13 Apr 2020
ANI Announces FDA Acceptance of Supplemental Filing for Cortrophin(R) Gel 80 U/mL
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Apr 2020
U.S. FDA Grants CytoSorb(R) Emergency Use Authorization for Use in Patients with COVID-19 Infection
Devices FDA

HSMN NewsFeed - 9 Apr 2020
EMD Serono and Pfizer Receive US FDA Breakthrough Therapy Designation and Submit Application for BAVENCIO(R) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 Apr 2020
Viracta Receives Welcome FDA Guidance at Type C Meeting for the Treatment of EBV-Associated Lymphomas
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 Apr 2020
Soliton Granted New Key Patent for FDA Cleared RAP Technology
Devices

HSMN NewsFeed - 7 Apr 2020
FDA expedites approval of Cochlear's Remote Check solution for cochlear implants
Devices FDA Product Launch

HSMN NewsFeed - 6 Apr 2020
Perrigo Announces FDA Approval for the Store Brand Equivalent of Voltaren(R) Arthritis Pain
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 6 Apr 2020
Luminex Receives FDA Emergency Use Authorization for ARIES(R) SARS-CoV-2 Assay to Detect Virus Responsible for COVID-19 Disease
Diagnostics FDA

HSMN NewsFeed - 6 Apr 2020
HEMA Biologics(TM) Announces FDA Approval of SEVENFACT(R) [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Apr 2020
Mallinckrodt Initiates Rolling Submission of Biologics License Application for StrataGraft(R) Regenerative Skin Tissue to U.S. Food and Drug Administration
Regenerative Medicine FDA

HSMN NewsFeed - 6 Apr 2020
Co-Diagnostics, Inc Receives FDA Emergency Use Authorization for COVID-19 Test
Diagnostics FDA Product Launch

HSMN NewsFeed - 3 Apr 2020
BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in U.S.
Diagnostics FDA

HSMN NewsFeed - 31 Mar 2020
enlightenVue's Single-Use Micro Endoscope Receives FDA 510(k) Clearance
Devices Surgery FDA

HSMN NewsFeed - 30 Mar 2020
Lilly's Taltz(R) (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 27 Mar 2020
Cipla Receives Final Approval for Generic Version of AstraZeneca Pharmaceutical's Nexium(R) (Esomeprazole for Oral Suspension 10mg, 20mg and 40mg)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 27 Mar 2020
EchoNous, Inc. Announces FDA Approval for Its New KOSMOS Platform
Devices FDA

HSMN NewsFeed - 26 Mar 2020
FDA Grants VERO Biotech Expanded Access Emergency Use for the Treatment of Patients with COVID-19, with the GENOSYL(R) DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 24 Mar 2020
BIOLASE Announces Regulatory Clearance of Laser Bacterial Reduction Therapy Indication for Epic Hygiene Laser
Devices Dental FDA

HSMN NewsFeed - 23 Mar 2020
Biohaven to Advance Vazegepant into Phase 3 for the Acute Treatment of Migraine Following Successful End of Phase 2 Meeting with FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Mar 2020
Accelerated Road to Market Approval for CERAMENT(R) G in the US - BONESUPPORT(TM) Submits De Novo Application
Devices Orthopaedic Drug Delivery FDA

HSMN NewsFeed - 20 Mar 2020
Biostage Announces IND Approval from FDA for its Lead Product Candidate Cellspan(TM) Esophageal Implant
Devices Regenerative Medicine FDA

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