FDA Orders Supernus to Stop Misleading Promotion of Oxtellar XR November 10, 2016 It’s indicated as an adjunctive therapy for partial seizures. Read More
Japan Green Lights Medinol Stent Trial November 9, 2016 Japan granted clinical trial notification to confirm the device’s safety and efficacy. Read More
Cempra Drug Stalled Over Wockhardt Manufacturing Concerns November 9, 2016 Wockhardt has been sanctioned by the FDA twice this year. Read More
EOS Imaging Receives FDA 510(k) Clearance for kneeEOS 3D Surgical Planning Software November 8, 2016 The software is able to analyze and make a proposal for the size selection and position. Read More
Laboratory Controls, Sanitation Issues Lead to Form 483 for Syntese November 8, 2016 The firm did not conduct any microbiological tests on its API prior to its release to the U.S. market. Read More
Propeller Health Receives FDA Clearance for the Propeller Platform November 7, 2016 The device is designed to help patients and their physicians better understand asthma and COPD. Read More
Chinese Regulators Move Forward on IND Review November 7, 2016 The CFDA announced sweeping reforms to China’s nine-year-old drug registration rules. Read More
FDA Approves Respiratory Infection Early Detection Device November 4, 2016 The diagnostic test can detect 14 viral and bacterial pathogens. Read More
EMA Probing Wanbury for Falsifying Labels November 4, 2016 India’s export certificate for Wanbury was issued after a June inspection. Read More
Arterys Receives 510(k) Clearance for Arterys Software November 3, 2016 The software will be used in clinical settings for the quantification of cardiac flow. Read More
China Spells Out License Renewal Requirements for Radioactive Drugs November 3, 2016 License holders will have to submit verification documents, a GMP certificate and a self-examination report. Read More
Health Canada Approves Edwards Intuity Heart Valve November 2, 2016 The device is designed to create more time during the treatment of complex heart failure cases. Read More