Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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Accelerated Approval Is US FDA Panel’s Preferred Path For Biogen/Ionis’s Tofersen In ALS
Advisory committee unanimously concludes that the reduction in plasma neurofilament light chain concentration is reasonably likely to predict clinical benefit in SOD1-ALS, but majority of panelists say convincing evidence of efficacy to support regular approval has not been demonstrated.
FDA Adds More MDRs, Deaths, To Philips Ventilator Tally
Less than a month after Philips released test results that it said showed the company’s much scrutinized sleep therapy devices were safe, the FDA has reported more complaints, including deaths, associated with the machines.
Novo Nordisk In Negotiations To Acquire Medical Device Maker Biocorp For About $165M (€154M)
After a nearly two-year collaboration, Novo Nordisk said it has begun talks to buy a controlling stake in French medical device company Biocorp.