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Healthcare News Roundup: Regulatory

 HSMN NewsFeed - 19 Mar 2019
Abbott Announces CE Mark for Alinity(TM) m Diagnostics System and Assays, the Latest in Molecular Technology, to Help Deliver Critical Test Results and Benefits to Patients
Diagnostics Regulatory
 HSMN NewsFeed - 18 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
Biopharmaceuticals FDA Regulatory
 HSMN NewsFeed - 13 Mar 2019
Boston Scientific Receives CE Mark for Next Generation WATCHMAN FLX(TM) Left Atrial Appendage Closure Device
Devices Interventional Cardiology Regulatory
 HSMN NewsFeed - 8 Mar 2019
Positive Interim Analysis in Pivotal IsoConDa Phase III Study
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 7 Mar 2019
Aethlon Medical, Inc. Announces Appointment of Lisa M. Boswell as Director, Quality Systems and Regulatory Affairs
Devices Personnel
 HSMN NewsFeed - 6 Mar 2019
Ampio Updates Regulatory Status for Ampion
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Mar 2019
CHMP Recommends Approval of Dupixent(R) (dupilumab) for Asthma Indication
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 1 Mar 2019
AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI(TM)) for the Treatment of Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology Regulatory
 HSMN NewsFeed - 28 Feb 2019
Daiichi Sankyo Europe and Esperion Announce Validation of the Marketing Authorisation Application (MAA) for Bempedoic Acid and the Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet
Biopharmaceuticals Cardiology Regulatory
 HSMN NewsFeed - 26 Feb 2019
Thermo Fisher Scientific's Oncomine Dx Target Test Receives Expanded Regulatory Approval in Japan
Diagnostics Oncology Regulatory
 HSMN NewsFeed - 21 Feb 2019
Denovo Biopharma Announces New Hires for Positions of Chief Medical Officer of Hematology and Senior Vice President, Regulatory Affairs and Quality Assurance
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 19 Feb 2019
Bioness StimRouter(R) Neuromodulation System Receives European CE Mark Approval for the Treatment of Overactive Bladder (OAB)
Devices Neurology Urology Regulatory
 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 - 4 Feb 2019
CHMP Recommends Approval of Praluent(R) (alirocumab) Injection to Reduce Cardiovascular Risk in People with Established Atherosclerotic Cardiovascular Disease
Biopharmaceuticals Cardiology Regulatory
 HSMN NewsFeed - 1 Feb 2019
CTI BioPharma Receives Results of the CHMP Oral Explanation for Pacritinib in the Treatment of Myelofibrosis and Provides Development Update
Biopharmaceuticals Regulatory
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