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Healthcare News Roundup: Regulatory

 HSMN NewsFeed - 9 Apr 2019
Bluejay Diagnostics, Inc. Announces CE Mark For Its Allereye(R) Tear Total IgE Test
Diagnostics Regulatory
 HSMN NewsFeed - 3 Apr 2019
Pursuit Vascular Announces CE Mark Approval for ClearGuard HD Caps
Devices Regulatory Product Launch
 HSMN NewsFeed - 1 Apr 2019
OncoSec Announces Advanced Therapy Medicinal Product Classification from the EMA for TAVO(TM) in Refractory Metastatic Melanoma
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 26 Mar 2019
AbbVie Announces First Regulatory Approval of SKYRIZI(TM) (risankizumab) for the Treatment of Plaque Psoriasis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis and Psoriatic Arthritis in Japan
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 25 Mar 2019
Israel Approves CytoSorb Registration, CytoSorbents Announces Gad Medical as Distributor
Devices Regulatory Distribution
 HSMN NewsFeed - 25 Mar 2019
Elekta Unity MR-linac Receives Medical Device License From Health Canada
Devices Radiology Oncology 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
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