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  • FDA clears Johnson & Johnson’s surgical robot for ‘the next era in surgery’
    The FDA has authorized Johnson & Johnson’s Ottava Robotic Surgical System as the company looks to compete with Intuitive Surgical and Medtronic.
    Fierce Biotech · 7d ago↗ source
  • Midwest Poultry Services. L.P. Recalls Shell Eggs Due to Possible Salmonella Enteritidis Contamination
    Midwest Poultry Services, L.P. is voluntarily recalling 1,589,577 dozen white shell eggs and brown cage free shell eggs produced in Texas because they have the potential to be contaminated with Sal…
    fda recalls · 7d ago↗ source
  • Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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raps · 7d ago
↗ source
  • Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies
    The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.
    raps · 7d ago↗ source
  • Study: Most sponsors complete postmarketing trials, publish results
    Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the tim…
    raps · 7d ago↗ source
  • FDA advisory committee backs two controversial peptides
    An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound t…
    raps · 7d ago↗ source
  • STAT+: What is a ‘world model’? Nabla’s Alex LeBrun explains
    In this edition of AI Prognosis, Brittany Trang talks to Alex LeBrun, AI scribe company Nabla's executive chairman, about an alternative to LLMs
    STAT · 7d ago↗ source
  • New study supports testing of Merck’s Ebola vaccine in DRC outbreak
    New data supports the idea that Merck’s Ebola vaccine Ervebo, licensed to target the Zaire species of ebolaviruses, could also offer some protection against another.
    STAT · 7d ago↗ source
  • FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
    The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
    fda press · 7d ago↗ source
  • Opinion: What Argentina’s World Cup loss should teach American hospitals
    “Hospitals often make Argentina’s mistake: We confuse continuity with progress,” writes physician, hospital administrator, and bioethicist Basel Tarab.
    STAT · 7d ago↗ source
  • Congo’s Ebola outbreak has killed over 1,000 people
    At least 999 people have died from the Ebola outbreak in Congo, a grim toll in what’s already been declared the fastest Ebola outbreak in history.
    STAT · 7d ago↗ source
  • NIH joins Trump’s $5B AI mission with biomedical research push
    The U.S. Department of Health and Human Services announced new efforts Wednesday aligned with President Donald Trump’s artificial intelligence-driven Genesis Mission. The centerpiece of HHS’ partic…
    Fierce Biotech · 7d ago↗ source
  • STAT+: Pharma tries to tamp down broad China restrictions
    AI-focused VC firm raises $800M, Merck's new cholesterol pill, and more biotech news from The Readout
    STAT · 7d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Trump’s plan for tariffs on generics, a Merck and Gilead HIV pill, and more
    President Trump plans to impose tariffs on imported generic medicines, his latest threat aimed at bringing pharmaceutical manufacturing back to the U.S.
    STAT · 7d ago↗ source
  • FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
    The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again.
    fda press · 7d ago↗ source
  • Job dissatisfaction and health care access uncertainty grows in the U.S., new study finds
    What Hawaii's wildfires can teach the nation about health recovery, 4.5 million people disenrolled from SNAP, and more health news
    STAT · 7d ago↗ source
  • House passes bill directing FDA to update animal testing rules
    The U.S. House of Representatives passed the FDA Modernization Act 3.0 this week, and lawmakers and animal welfare advocates are celebrating the bill as a step toward a new era in preclinical testi…
    Fierce Biotech · 7d ago↗ source
  • STAT+: ‘Cochlear implant for blindness’ debuts in Europe, could launch in U.S. in 2027
    Science Corporation announced the European launch of its retinal implant for patients with age-related macular degeneration.
    STAT · 7d ago↗ source
  • Royalty Pharma pens $425M deal for slice of sales on AstraZeneca’s ATTR drug
    Royalty Pharma has secured a stake in another transthyretin-mediated amyloidosis drug, this time paying $125 million upfront to Neurimmune for a cut of the sales of its AstraZeneca-partnered med.
    Fierce Biotech · 7d ago↗ source
  • As Maui recovers from devastating fires, a study offers vision for new rural health model
    A study of the long-term health impact of the Lahaina wildfires is inspiring a new model for disaster recovery and support.
    STAT · 8d ago↗ source
  • Opinion: STAT+: Hospitals’ AI may be drifting. Who’s watching?
    Senior leaders must treat AI governance as their own daily job, not something the technology committee handles quarterly, write Peter Pronovost, Justin Norden, and Kedar Mate.
    STAT · 8d ago↗ source
  • Opinion: STAT+: I’m a cardiologist. I’m not sure the new cholesterol drug enlicitide is a game-changer
    “In truth, I don’t anticipate prescribing patterns changing immediately,” cardiologist Vishal Khetpal writes of the new cholesterol drug Lipfendra.
    STAT · 8d ago↗ source
  • STAT+: Federal health quality research grants worth $109 million ended early
    At least 78 AHRQ grants worth $200 million have been affected by "non-award" notices; it's estimated those grants had $109.2 million in funding remaining.
    STAT · 8d ago↗ source
  • Celldex ends skin disease program after failing phase 2 test
    A phase 2 study of Celldex’s barzolvolimab in a chronic skin disease has missed its primary endpoint, driving the biotech to end development in the indication and raising doubts about an upcoming e…
    Fierce Biotech · 8d ago↗ source
  • STAT+: More workers hate their jobs, but keep them for the health insurance
    A new survey reveals 24% of U.S. workers stay in unwanted jobs to keep health insurance. Experts call it 'job lock.'
    STAT · 8d ago↗ source