GORE EXCLUDER Iliac Branch Lands FDA Approval March 3, 2016 It is the first off-the-shelf aortic branch device approved in the U.S. Read More
AbbVie Receives Orphan Drug Status for Venetoclax March 3, 2016 The EMA has granted orphan drug designation to venetoclax for the treatment of acute myeloid leukemia. Read More
FDA Awards Clearance to Reapplix’s 3C Patch System March 2, 2016 The system prepares platelet-rich plasma gel from peripheral blood. Read More
EMA Backs Acalabrutinib for Orphan Status in 3 Indications March 2, 2016 The recommendations are for the treatment of chronic lymphocytic leukemia, mantle cell lymphoma and lymphoplasmacytic lymphoma. Read More
EOS Imaging Gains CE Mark for spineEOS March 1, 2016 The system relies on EOS bi-planar imaging to create treatment plans focused on achieving sagittal alignment. Read More
Sanofi Cans Agreement With Kaléo Following Auvi-Q Recalls March 1, 2016 Sanofi will return U.S. and Canadian rights to the epinephrine injection to the company. Read More
ScandiDos’ Delta Discover Secures FDA Clearance February 29, 2016 Delta Discover is the first device that independently verifies all dosage delivery parameters. Read More
Senate Committee Tackles Right to Try Issue for Terminally Ill Patients February 29, 2016 A Senate committee is pressing the FDA to provide information on its expanded access program for drugs. Read More
EU Approves Dentsply-Sirona Merger for $5.56B February 26, 2016 The approval followed an agreement to extend licensing agreements between Sirona and its main suppliers. Read More
Trevena Gets FDA Breakthrough Therapy Designation for Oliceridine February 26, 2016 Oliceridine is eligible for FDA guidance on its development program. Read More
APN Health Garners FDA Clearance for Cardiac Mapping System February 25, 2016 Navik 3D is a cardiac mapping system focused on minimizing the cost and complexity of electrophysiology procedures. Read More
Novartis Wins Breakthrough Status for AML Candidate February 25, 2016 PKC412 is an experimental treatment for adults with newly diagnosed acute myeloid leukemia. Read More