Simplifying Global Compliance
The FDA has cleared St. Paul-based Cardiovascular Systems’ Diamondback 360 60cm systems for patients with peripheral artery disease. Read More
The new labeling will reflect increased risks of death for patients with ventilator-associated pneumonia. Read More
The European Patent Office has sided with Medtronic in a patent infringement case pitting CoreValve against Edwards’ Sapien valve. Read More
Novartis has scored a five-year extension of its U.S. patent of the multiple sclerosis drug Gilenya. Read More
Mauna Kea Technologies has received FDA clearance for two of its urological confocal miniprobes. Read More
Eisai and Biogen Idec have signed an agreement to develop and commercialize multiple potential treatments for Alzheimer’s disease. Read More
The FDA has asked Atossa Genetics to provide more information on its 510(k) application for the ForeCYTE nipple aspiration test. Read More
InControl Medical said Tuesday it has received FDA clearance on an expanded indication for its InToneMV incontinence device. Read More
The UK’s NICE has asked Alexion Pharmaceuticals for more information on the pricing of Soliris. Read More
MITA is launching a multimedia campaign called Imaging Forward to highlight the benefits and advances of medical imaging. Read More
AstraZeneca has received FDA approval for its once-per-week Bydureon pen. Read More
The EMA’s CHMP issues positive opinion for tablet formulation of Merck’s antibiotic Noxafil.
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