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Healthcare News Roundup: 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
 HSMN NewsFeed - 20 Dec 2018
FDA Accepts HETLIOZ(R) (tasimelteon) Supplemental New Drug Application for Review in the Treatment of Jet Lag Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Dec 2018
Eiger Announces Breakthrough Therapy Designation Granted by FDA for Lonafarnib in Progeria and Progeroid Laminopathies
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Dec 2018
FDA Grants Fast Track Designation to the Baricitinib Development Program for the Treatment of Systemic Lupus Erythematosus (SLE)
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Dec 2018
Ampio Updates Regulatory Status for Ampion
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Dec 2018
Merck KGaA, Darmstadt, Germany Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Dec 2018
Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection
Devices Interventional FDA
 HSMN NewsFeed - 5 Dec 2018
Olympus Spiration(R) Valve System Is FDA Approved for the Endobronchial Treatment of Emphysema
Devices FDA
 HSMN NewsFeed - 5 Dec 2018
Bausch & Lomb Receives 510(K) Clearance From FDA For Bausch & Lomb Ultra(R) Multifocal For Astigmatism Contact Lenses
Devices Ophthalmology FDA
 HSMN NewsFeed - 5 Dec 2018
Subtle Medical Receives FDA 510(k) Clearance and CE Mark Approval for SubtlePET(TM)
Devices Radiology FDA Regulatory
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