Sanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors.
Peter Marks’ March 28 letter giving one week’s notice of his resignation as director of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) is sending more ripples of uncertainty throughout the industry. Marks, who has helmed CBER for nearly a decade, blamed his departure on recently confirmed Health and Human Services (HHS) Secretary Robert Kennedy, who has made a career out of his anti-vaccine stance.
In a move that undoubtedly has the unspoken support of the medical device industry, the U.S. Environmental Protection Agency (EPA) reported it will revisit several rules governing emissions that affect a broad swath of industries.
Australia’s top universities are looking more to Asia for research collaborations following threats from the Trump administration to stop funding research at institutions that don’t comply with U.S. narratives.
Abbott Laboratories snagged a CE mark for its Volt pulsed field ablation catheter for atrial fibrillation several months earlier than the mid-year approval expected. The Abbott Park, Ill.-based company has begun Volt’s commercial launch with the physicians who participated in its European clinical trials and plans to expand to other users on the continent in the second half of 2025.
The U.S. Department of Health and Human Services HHS reported a plan to reduce staffing by 10,000 in an immediate reduction, which when paired with retirement initiatives will drop staffing by as many as 20,000.
The U.S. FDA gave the green light to Nanosonics Ltd.’s Coris system via de novo clearance for reducing infection risk by delivering improved cleaning outcomes for flexible endoscopes, especially the complex channels of endoscopes that are prone to biofilm build up.
The U.S. Senate has approved the nominations of two key members of the Trump administration, Marty Makary as FDA commissioner and Jay Bhattacharya as NIH director. While these are two of the most critical appointments for the Trump administration, the Senate still has two other important appointments in queue, including the directors of the Centers for Medicare & Medicaid Services and the CDC.
Biomérieux SA recently received U.S. FDA 510(k) clearance for its Vitek Compact Pro, a system for microorganism identification and Antibiotic Susceptibility Testing. The company hopes that the system will help clinical laboratories combat antimicrobial resistance and diagnose infectious diseases as well as support industrial laboratories in identifying contaminants to ensure consumer safety.
The FDA reported March 25 that Smiths Medical Inc., is recalling a series of oral and nasal endotracheal tubes because the diameters of the tubes may present with “a smaller diameter than expected.”
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