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Healthcare News Roundup: FDA

 HSMN NewsFeed - 26 Dec 2019
OBI Pharma Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Dec 2019
Correvio Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 23 Dec 2019
Lannett Receives FDA Approvals For Two Dosage Strengths Of Butalbital, Acetaminophen And Caffeine Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 19 Dec 2019
Interscope announces new FDA Clearance of the EndoRotor(R), for use in Airway procedures including in Interventional Pulmonology
Devices Interventional Pulmonology FDA
 HSMN NewsFeed - 16 Dec 2019
FDA Approves Diffusion-Weighted Images for Elekta Unity, Expanding Options for Assessment During Therapy
Devices Oncology FDA
 HSMN NewsFeed - 11 Dec 2019
FDA clears Cochlear's innovative new Osia(R) 2 hearing implant system
Devices FDA
 HSMN NewsFeed - 11 Dec 2019
Correvio Announces Intention to Explore Strategic Alternatives to Maximize Stakeholder Value
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 10 Dec 2019
Neuspera Medical Receives Investigational Device Exemption for Its Ultra-Miniaturized Implantable Device
Devices Urology Neurology FDA
 HSMN NewsFeed - 10 Dec 2019
Shoulder Innovations Announces FDA 510(k) Clearance For InSet Plus(TM) Augmented Glenoids For Total Shoulder System
Devices Orthopaedic FDA
 HSMN NewsFeed - 9 Dec 2019
BIOLASE Announces Clearance of the Epic Hygiene Laser for Dental Hygienists
Devices Dental FDA Product Launch
 HSMN NewsFeed - 9 Dec 2019
HIZENTRA(R) (Immune Globulin Subcutaneous [Human] 20% Liquid) Receives Orphan-Drug Exclusivity for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 6 Dec 2019
3DBio Therapeutics Receives FDA Rare Pediatric Disease Designation for AuriNovo(TM) for Ear Reconstruction in Microtia Patients
Devices Regenerative Medicine FDA
 HSMN NewsFeed - 5 Dec 2019
MolecuLight Receives FDA 510(k) Clearance for its i:X(R) Handheld Fluorescence Imaging Device for Wound Management
Devices Diagnostics Wound Care FDA
 HSMN NewsFeed - 4 Dec 2019
Vicarious Surgical Announces Breakthrough Designation by the FDA, Appoints Scott Huennekens to Board of Directors
Devices Surgery FDA Personnel
 HSMN NewsFeed - 2 Dec 2019
Cumberland Pharmaceuticals Receives FDA Approval for RediTrex(TM) Product Line
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Nov 2019
Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora(R) for the Prevention of Pregnancy
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Nov 2019
INHIBITOR Therapeutics Submits Investigational New Drug Application for Treatment of Patients with Late-Stage Prostate Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Nov 2019
Levo Therapeutics Receives Fast Track Designation From FDA for Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome
Biopharmaceuticals Neurology Drug Delivery FDA
 HSMN NewsFeed - 18 Nov 2019
Protalix BioTherapeutics and Chiesi Farmaceutici Announce Successful pre-BLA Meeting with FDA for Accelerated Approval of pegunigalsidase alfa for the Treatment of Fabry Disease in the United States
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Nov 2019
Ultromics Receives FDA Clearance for its AI-powered Decision Support System, EchoGo Core
Devices Cardiology FDA
 HSMN NewsFeed - 11 Nov 2019
Allergan Receives FDA Qualified Infectious Disease Product (QIDP) Designation And Fast Track Designation For ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Nov 2019
AI Medical Service Inc. announces FDA Breakthrough Device Designation for endoscopic AI system
Devices Gastroenterology FDA
 HSMN NewsFeed - 11 Nov 2019
Lipocine Receives Complete Response Letter for TLANDO(TM) from U.S. FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Nov 2019
Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA(R) (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Nov 2019
EIP Pharma Announces U.S. FDA Grants Fast-Track Designation to Neflamapimod as a Treatment for Dementia with Lewy Bodies (DLB)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 5 Nov 2019
Nevro Announces U.S. Launch of Senza(R) Omnia(TM) Spinal Cord Stimulation System to Treat Chronic Pain
Devices Neurology FDA Product Launch
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