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Healthcare News Roundup: Regulatory

 HSMN NewsFeed - 2 Dec 2019
CryoLife Receives CE Mark for E-nside Thoraco-abdominal Stent Graft
Devices Interventional Regulatory
 HSMN NewsFeed - 15 Nov 2019
Rigel Receives Positive CHMP Opinion for Fostamatinib Disodium Hexahydrate for Adult Patients with Chronic Immune Thrombocytopenia (ITP) in Europe
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 15 Nov 2019
Jazz Pharmaceuticals Receives Positive CHMP Opinion for Solriamfetol to Improve Wakefulness and Reduce Excessive Daytime Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 7 Nov 2019
Biocept Announces CE IVD Marks and Availability of its CEE-Sure(R) Blood Collection Tube and Sample Collection Shipping Kit in Europe
Diagnostics Oncology Regulatory Product Launch
 HSMN NewsFeed - 6 Nov 2019
Edwards SAPIEN 3 TAVI Receives Expanded Approval In Europe
Devices Interventional Cardiology Regulatory
 HSMN NewsFeed - 30 Oct 2019
European Commission Approves Astellas' XOSPATA(TM) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with Mutations Detected using Invivoscribe's LeukoStrat(R) CDx FLT3 Mutation Assay
Diagnostics Oncology Regulatory
 HSMN NewsFeed - 25 Oct 2019
European Commission Approves Astellas' XOSPATA(TM) (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 24 Oct 2019
Provention Bio Announces PRV-031 (Teplizumab) Granted PRIME Designation by the European Medicines Agency
Biopharmaceuticals Endocrinology Regulatory
 HSMN NewsFeed - 22 Oct 2019
BioGX Receives CE-IVD Mark For Enhanced Flu Assay
Diagnostics Regulatory
 HSMN NewsFeed - 21 Oct 2019
Perflow Medical Receives CE Mark Approval of Novel Cascade(TM) Agile
Devices Neurology Interventional Regulatory
 HSMN NewsFeed - 18 Oct 2019
On Target Laboratories Appoints Vice President of Regulatory and Quality
Diagnostics Oncology Personnel
 HSMN NewsFeed - 18 Oct 2019
AbbVie Receives CHMP Positive Opinion for Upadacitinib (RINVOQ(TM)) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 18 Oct 2019
EVENITY(R) (Romosozumab) Receives Positive CHMP Opinion For The Treatment Of Severe Osteoporosis In Postmenopausal Women At High Risk Of Fracture
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 16 Oct 2019
Fidmi Medical Receives FDA Regulatory Clearance for Low-profile Enteral Feeding Device
Devices FDA
 HSMN NewsFeed - 15 Oct 2019
BIOLASE Announces First-Ever U.S. & Canada Regulatory Clearance of Laser Crown and Veneer Removal
Devices Dental FDA Regulatory
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