Norman Sharpless, director of the National Cancer Institute, will become “acting” commissioner of FDA after commissioner Scott Gottlieb abruptly announced he is leaving the position.
As the Irvine, CA-based company strengthens its mitral valve portfolio, it also faces a lawsuit from Abbott Laboratories over the Pascal system.
The agency released a letter to healthcare providers pointing out the risks and said it would hold a public advisory committee meeting.
Ablative Solutions revealed data from the Peregrine Post-Market Study during the 2019 Cardiovascular Research Technologies meeting in Washington D.C. recently.
A successor has not yet been named and it is expected that Gottlieb will leave the position sometime next month.
Parsippany-Troy Hills, NJ-based Pacira Pharmaceuticals to pay up to $120 million cash up front and an additional $100 million upon the achievement of milestones under the terms of the deal.
Yann Fleureau, co-founder and CEO of Cardiologs, weighs in on why 2019 will be known as the year of validation for artificial intelligence.
The company said the pause in sales was temporary and that it was not related to the performance and safety of Recell.
Product launches, study results, and approvals were signs of a pretty significant week in diagnostics, as FDA, CMS, and CDC formed a task force to make diagnostics rapidly available during public health emergencies.
Rani Therapeutics has conducted the first human study of a robotic capsule set to replace injections.
Influenza and its complications cause as many as 140,000 to 710,000 hospitalizations and 12,000 to 56,000 deaths annually in the U.S.