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Healthcare News Roundup: Regulatory

 HSMN NewsFeed - 19 Jul 2019
Halozyme Announces Janssen Submits Extension Application To European Medicines Agency For Subcutaneous Formulation Of DARZALEX(R) Utilizing ENHANZE(R) Technology
Biopharmaceuticals Oncology Drug Delivery Regulatory
 HSMN NewsFeed - 19 Jul 2019
Aridis Pharmaceuticals Receives Orphan Drug Designation From the European Medicines Agency for AR-501
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 16 Jul 2019
Novian Health Obtains CE Mark for Novilase Breast Therapy
Devices Regulatory
 HSMN NewsFeed - 28 Jun 2019
Amgen and UCB Provide Regulatory Update on Status of EVENITY(TM) (romosozumab) in the EU
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 25 Jun 2019
IRRAS Wins Regulatory Approval of IRRAflow(R) in Israel and Costa Rica
Devices Neurosurgery Monitoring Regulatory
 HSMN NewsFeed - 10 Jun 2019
Eiger Appoints Industry Veteran and Regulatory Affairs Expert Mark Mannebach, PhD, RPh as Vice President of Global Regulatory Affairs
Biopharmaceuticals Personnel
 HSMN NewsFeed - 29 May 2019
ReWalk Robotics Receives CE Mark for ReStore(TM) Exo-Suit Stroke Rehabilitation Device
Devices Regulatory
 HSMN NewsFeed - 28 May 2019
BioMarin Announces that Phase 3 Cohort of Valoctocogene Roxaparvovec, Gene Therapy Study in Severe Hemophilia A Met Pre-Specified Criteria for Regulatory Submissions in the U.S. and Europe
Biopharmaceuticals
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