The decision stood in contrast with the agency’s highly controversial approval of Sarepta’s previous DMD drug, Exondys 51. The company’s shares fell sharply in after-hours trading. Source link
The name-and-shame strategy is taken out of the playbook of the healthcare quality movement, which Ciitizen claims has moved the needle in helping to improve measurement and reporting standards by providers nationwide. Source link
Reuters reported that the drug, Rinvoq, will carry a list price of $59,000 per year. AbbVie’s top-selling drug, Humira, is also approved for treating RA. Source link
Text FDA Approved appearing behind ripped brown paper.
The agency said Friday that it had approved Celgene’s Inrebic (fedratinib), the first new drug approved for the disease – a type of rare blood cancer – since the approval of Incyte’s Jakafi. Source link
The company offers personalized 3-D printed clear aligners – essentially a form of transparent plastic braces – in a direct to consumer model that it touts as cheaper and more convenient than traditional options. Source link
Medical devices must be managed from a security perspective, but also from an operational perspective. Using analytics to establish behavior baselines helps support risk assessments, find malfunctions and enhance staff productivity. Source link
Canyon’s New Road E-Bike Absolutely Flies The online bike brand is on to a winner with its latest electric release, the Roadlite:ON ...
Rolling out the ratings nationwide is part of the Trump Administration’s larger initiative to inject cost and quality transparency into the healthcare system. Source link
Red seal and imprint "FDA APPROVED" on white surface. FDA - Food and Drug Administration is a federal agency of the United States Department of Health and Human Services.
On Thursday, Roche’s Rozlytrek won simultaneous FDA labels for NTRK fusion-positive solid tumors and ROS1-positive non-small cell lung cancer. Source link
Juliana Garaizar’s removal marks the second time in the past 12 months that TMC’s leadership is making executive changes at the very top of organizations under its umbrella that are dedicated to innovation. Source link

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