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Healthcare News Roundup: Regulatory

 HSMN NewsFeed - 9 Nov 2018
Jazz Pharmaceuticals Submits Marketing Authorization Application to European Medicines Agency for Solriamfetol as a Treatment to Improve Wakefulness and Reduce Excessive Daytime Sleepiness in Adult Patients with Narcolepsy or Obstructive Sleep Apnea
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 5 Nov 2018
EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 2 Nov 2018
TempTraq(R) Wearable Temperature Monitoring Patch Earns CE Mark Approval
Devices Monitoring Regulatory
 HSMN NewsFeed - 1 Nov 2018
AbbVie Receives European Commission Approval of VENCLYXTO(R) (venetoclax) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 23 Oct 2018
BioGX Launches 5 new CE Mark IVD Tests, Expands Sexual Health Panels on the BD MAX(TM)
Diagnostics Regulatory Product Launch
 HSMN NewsFeed - 19 Oct 2018
Mylan and Biocon Announce Positive CHMP Opinion for Ogivri(R), Biosimilar Trastuzumab
Biopharmaceuticals Generics Oncology Regulatory
 HSMN NewsFeed - 17 Oct 2018
Adam Hacker, PhD Joins Autolus as Senior Vice President for Regulatory Affairs and Quality
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 17 Oct 2018
Thermo Fisher Scientific CE Marks Oncomine Dx Target Test
Diagnostics Oncology Regulatory
 HSMN NewsFeed - 15 Oct 2018
CIVCO Radiotherapy Announces FDA 510k Clearance and CE Mark of their Solstice SRS Immobilization System
Devices Oncology FDA Regulatory
 HSMN NewsFeed - 11 Oct 2018
Rigel Receives EMA Validation of the Marketing Authorization Application for Fostamatinib Disodium Hexahydrate in Chronic Immune Thrombocytopenia (ITP) in Adult Patients
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 10 Oct 2018
OSE Immunotherapeutics and Oncology Physician Network GERCOR Announce Submission of Investigational New Drug Application to Evaluate Tedopi(R) in Combination with Nivolumab in Pancreatic Cancer
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 3 Oct 2018
SI-BONE, Inc. Announces that NICE, the UK National Institute for Health and Care Excellence, Published Medical Technology Guidance Finding that the Evidence Supports Treatment of Sacroiliac Joint Pain with the iFuse Implant System(R)
Devices Orthopaedic Neurosurgery Regulatory
 HSMN NewsFeed - 24 Sep 2018
Kyorin Receives Approval from Japan's Ministry of Health, Labour and Welfare for Vibegron for Overactive Bladder
Biopharmaceuticals Urology Regulatory
 HSMN NewsFeed - 21 Sep 2018
Lilly Receives Positive CHMP Opinion for Emgality(TM) (galcanezumab) for the Prophylaxis of Migraine in Adults
Biopharmaceuticals Neurology Regulatory
 HSMN NewsFeed - 21 Sep 2018
CHMP Recommends Approval of Buvidal(R) (CAM2038) for the Treatment of Opioid Dependence
Biopharmaceuticals Regulatory
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