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Healthcare News Roundup: FDA

 HSMN NewsFeed - 20 Feb 2019
Hygieia Receives 510(k) Clearance from FDA for Phone App That Enhances Company's d-Nav Insulin Guidance Service
Devices Endocrinology FDA
 HSMN NewsFeed - 19 Feb 2019
AbbVie Announces New Drug Application Accepted for Priority Review by U.S. FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Feb 2019
NuVasive's Proprietary Magnetic Implant System To Be Used In First-Of-Its-Kind, All-Internal Bone Transport System
Devices Orthopaedic FDA Regulatory
 HSMN NewsFeed - 19 Feb 2019
ReWalk Announces 510k FDA Submission for ReStore(TM) Exo-Suit for Stroke Rehabilitation
Devices FDA
 HSMN NewsFeed - 14 Feb 2019
Lipocine Inc. Announces FDA Clearance of IND to Commence Phase 2 Study of LPCN 1144 in Biopsy Confirmed NASH Subjects
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Feb 2019
Bausch & Lomb Receives 510(k) Clearance For Use Of The Tangible(R) Hydra-PEG(R) Custom Contact Lens Coating Technology On Several Of Its Boston(R) Gas Permeable Lens Materials And Zenlens(TM) Family Of Scleral Lenses
Devices Ophthalmology FDA
 HSMN NewsFeed - 12 Feb 2019
U.S. FDA Approves DARZALEX(R) (daratumumab) Split-Dosing Regimen
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Feb 2019
BioDirection Receives Breakthrough Device Designation from FDA for Tbit(TM) System
Devices Diagnostics Neurology FDA
 HSMN NewsFeed - 11 Feb 2019
FDA Grants Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Cryptococcosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Feb 2019
BioLineRx Receives Orphan Drug Designation From the FDA for its Lead Therapeutic Candidate BL-8040 for the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 Jan 2019
U.S. FDA Approves IMBRUVICA(R) (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 25 Jan 2019
Zimmer Biomet Receives FDA Clearance for ROSA(R) Knee System for Robotically-Assisted Surgeries
Devices Orthopaedic FDA
 HSMN NewsFeed - 24 Jan 2019
BD Launches Ergonomic Pen Needle Technology to Help Optimize Injection Technique
Devices Drug Delivery FDA Product Launch
 HSMN NewsFeed - 21 Jan 2019
Abbott Offers a New Option for Physicians Treating Patients with Atrial Fibrillation
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 16 Jan 2019
Therachon is Granted Orphan Drug Designation by US FDA for Apraglutide for the Treatment of Short Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 14 Jan 2019
Amneal Announces Approval of Rivastigmine Transdermal System
Biopharmaceuticals Drug Delivery Generics FDA
 HSMN NewsFeed - 2 Jan 2019
Slayback Pharma Announces FDA Approval of Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml in a Multi-Dose Vial, the First Generic Equivalent of Makena(R) Injection 1,250 mg/ 5 ml Multi-Dose Vial
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 31 Dec 2018
FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management
Biopharmaceuticals Surgery FDA
 HSMN NewsFeed - 28 Dec 2018
Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 28 Dec 2018
PolarityTE Registers OsteoTE(TM) with U.S. Food and Drug Administration
Regenerative Medicine FDA
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