Terumo to Buy Sequent Medical June 14, 2016 The transaction is expected to close in July or August of this year. Read More
FDA Issues Heart Warning Linked to Imodium Overdose June 14, 2016 The agency is warning of potentially fatal heart problems linked to Imodium overdose. Read More
Masimo Gains FDA Clearance for O3 Regional Oximetry June 13, 2016 The device is designed to continuously monitor cerebral oxygen saturation. Read More
Ko Da Receives Warning Letter Over GMP Violations June 13, 2016 The violations surround the drugmakers’s quality control procedures. Read More
High Court Shoots Down GSK’s Bid to Dismiss Lawsuits Over Diabetes Drug June 10, 2016 The court denied GSK’s bid to throw out lawsuits from union health and welfare funds. Read More
GenMark Nabs CE Mark for ePlex System June 9, 2016 ePlex is a “sample-to-answer” system that detects numerous molecular targets on one test cartridge. Read More
Drugmakers Ask EMA to Provide Guidance, Harmonization And Flexibility For Advanced Therapies June 9, 2016 A report noted a lack of specific guidance and incongruent EU requirements. Read More
Gore Earns CE Mark for its Gore Excluder Conformable AAA Device June 8, 2016 The CE mark broadens the company’s menu of solutions for the endovascular treatment of aortic disease. Read More
EMA Releases Revised Guidelines for Risk Management Plans June 8, 2016 The updates apply to RMPs for products with centralized marketing authorization. Read More
NuVasive to Acquire Biotronic NeuroNetwork June 7, 2016 The acquisition is valued at $98 million. Read More
FDA Slaps Janssen’s Continuous Production Line With Form 483 June 7, 2016 The 483 documents a pre-approval inspection, citing three issues. Read More