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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Cowen Washington Research Group, European Commission, GE Healthcare
Whether large or small, or based in the U.S. or abroad, life sciences companies are an increasingly attractive target for shareholder suits. The number of securities fraud class action suits filed in the U.S. in 2019 across all industries totaled 404, just one more than the 403 cases filed in 2018 and down from the peak of 412 in 2017, according to a new Dechert LLP report.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
Ra Medical Systems Inc., of Carlsbad, Calif., reported that the U.S. FDA has granted investigational device exemption (IDE) approval to study its DABRA excimer laser system as an atherectomy device to treat peripheral vascular stenosis.
The latest global regulatory news, changes and updates affecting biopharma: Aegerion Pharmaceuticals Inc., Alexion Pharmaceuticals Inc., Insys Therapeutics Inc.
About a month-and-a-half earlier than expected, Horizon Therapeutics plc has won FDA approval for teprotumumab in thyroid eye disease (TED), a progressive autoimmune condition that disproportionately affects women.
SANTA CLARA, Calif. – Peter Thiel is not a fan of incremental science. The high-profile venture capital investor, who invests across technology and the life...
SAN FRANCISCO – Insulet Corp. aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod...
China announced Jan. 17 which further pharmaceutical companies it will buy from under its centralized procurement program that seeks the lowest prices. The price...
In response to the emergence of a new coronavirus seen recently in China, and now America, Novavax Inc. has initiated development of a vaccine candidate, the...
It is equally fair to say that lung cancer treatment has come a long way, and that it has a long way to go. Speaking at a joint conference by the International...
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