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  • UK regulator adopts AI framework for medical devices, launches next phase of AI sandbox
    The Medicines and Healthcare products Regulatory Agency announced that the UK government has accepted a set of recommendations on using artificial intelligence in medical devices. These recommendat…
    raps · 15d agoRegulatoryPositive↗ source
  • Hospitals Launch Cash‑Pay Longevity Clinics, Offering Intensive Health Monitoring
    Prestigious hospitals across the United States have begun offering cash‑pay longevity programs that promise comprehensive health monitoring for patients willing to spend thousands of dollars out of…
    STAT · 14d agoNeutral↗ source
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  • FDA outlines roadmap for AI guidance to be released in 2027
    The Food and Drug Administration announced a roadmap for new artificial intelligence guidance that it plans to publish in 2027. The upcoming guidances are expected to establish a framework for dev…
    STAT · 14d agoRegulatoryNeutral↗ source
  • Leader Formulas recalls RAPTURE pre-workout supplement after FDA finds DMAA in product
    Leader Formulas, LLC of Tomball, Texas announced a voluntary nationwide recall of one lot of its RAPTURE pre‑workout powder after testing revealed the presence of the stimulant 1,3‑dimethylamylamin…
    fda recalls · 14d agoCRLNegative↗ source
  • WHO releases updated draft guideline to strengthen quality risk management for manufacturers and regulators
    The World Health Organization has issued an updated draft guideline designed to help manufacturers establish effective quality risk management systems and to aid regulators in planning inspections.…
    raps · 15d agoRegulatoryNeutral↗ source
  • Trump proposes $90 monthly aid for seniors as stem cell therapies gain attention
    STAT's D.C. Diagnosis newsletter notes that stem cell treatments are being discussed as a possible next breakthrough in medicine, likening them to the rise of peptide therapies. President Trump an…
    STAT · 14d agoNeutral↗ source
  • Nuvig Therapeutics pauses CIDP trial of NVG-2089, cites enrollment and cost challenges
    Nuvig Therapeutics, backed by major pharmaceutical partners, announced it is stopping development of its lead fusion protein NVG-2089 for chronic inflammatory demyelinating polyradiculoneuropathy (…
    Fierce Biotech · 14d agoNegative↗ source
  • Nonprofit hospitals launch pricey longevity clinics offering personalized health assessments
    Longevity clinics, which promise individualized health advice and advanced testing, are now being opened by major nonprofit hospitals. The services aim to map the health trajectories of patients ac…
    STAT · 14d agoNegative↗ source
  • Study finds pulse oximeters at Johns Hopkins shifted from overestimating to underestimating oxygen, with larger errors in patients of color
    A retrospective analysis of five years of pulse‑oximeter data from Johns Hopkins Hospital shows a shift in measurement bias. Earlier research documented that the devices tend to overestimate oxyge…
    STAT · 14d agoNeutral↗ source
  • Pacific Health Sciences recalls Baby Sleep Gripe Water over undeclared alcohols
    Pacific Health Sciences announced a voluntary recall of one lot of its Babies' Magic Tea brand Baby Sleep Gripe Water dietary supplement. FDA testing identified undeclared ethanol, methanol and is…
    fda recalls · 14d agoCRLNegative↗ source
  • Infectious disease expert urges calm over mysterious pneumonia case in Siberia
    A 28‑year‑old laboratory worker at a Siberian institute that studies plague died after developing severe pneumonia, prompting a quarantine of a nearby hospital and monitoring of roughly 200 contact…
    STAT · 14d agoNeutral↗ source
  • When to get your flu shot: key factors to consider
    The article addresses the question of the optimal timing for a flu vaccination. It notes that deciding when to receive the shot can depend on several practical considerations. Readers are encourag…
    STAT · 14d agoNeutral↗ source
  • Eli Lilly's Jaypirca receives FDA approval for first-line treatment of untreated CLL and SLL
    Eli Lilly announced that the FDA has approved its drug Jaypirca as a first‑line therapy for patients with previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma. The appr…
    STAT · 15d agoApprovalPositive↗ source
  • Late-stage mRNA melanoma vaccine shows promise, slowing disease recurrence
    A late-stage trial of an mRNA-based cancer vaccine reported that the treatment halted the return of melanoma in patients, providing the first clear evidence of efficacy for this approach. Merck an…
    STAT · 15d agoPositive readoutPositive↗ source
  • FDA approves first expandable pediatric pulmonary heart valve
    The FDA has cleared a new surgically implanted pulmonary valve designed for children with congenital pulmonary valve disease. The device, called the Autus Size-Adjustable Valve, was developed by E…
    Fierce Biotech · 15d agoApprovalPositive↗ source
  • Vaxcyte’s 31-valent pneumococcal vaccine shows non-inferior immunity to Pfizer and Merck shots in Phase 3, shares surge
    Vaxcyte’s 31-valent pneumococcal candidate, VAX-31, was compared head‑to‑head with Pfizer’s Prevnar 20 and Merck’s Capvaxive in the late‑stage Opus‑1 study aimed at preventing invasive pneumococcal…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • CSL pays $355M upfront to co-develop Alentis’ phase-2 fibrosis drug lixudebart
    CSL of Australia has agreed to pay $355 million upfront for the rights to Alentis Therapeutics' anti-Claudin-1 drug lixudebart, a phase-2 fibrosis candidate. The agreement includes up to $1.2 bill…
    Fierce Biotech · 15d agoDealPositive↗ source
  • Genmab’s Rina-S ADC shows 9.5-month median PFS, touted as superior to AbbVie’s Elahere
    Genmab reported median progression‑free survival of 9.5 months for its FRα‑directed antibody‑drug conjugate Rina‑S in part C of the phase 1/2 Rainfol‑01 trial, which enrolled 109 patients with plat…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Nova Biomedical issues global correction for StatStrip Glucose Hospital Meter over software patient-ID error
    Nova Biomedical announced a global medical device correction for its StatStrip Glucose Hospital Meter System. The correction targets a software issue in the Gen 2.0 model that can leave prior pati…
    fda recalls · 15d agoCRLNegative↗ source
  • Nobel-winning optogenetics opens path to experimental therapies for blindness and Alzheimer’s
    Optogenetics, a technique that uses light to control neurons, earned a 2026 Nobel Prize. Researchers say the method is transforming brain mapping from a simple roadmap to a detailed, three-dimensi…
    STAT · 15d agoPositive↗ source
  • Trump administration issues new rules to standardize health-insurance pricing disclosures
    The Trump administration on Monday issued new regulations that require health-insurance companies to release cleaned-up spreadsheets showing the amounts they pay hospitals and physicians. The rules…
    STAT · 15d agoRegulatoryNeutral↗ source
  • Utah moves forward with AI-driven acne prescription pilot, Nolla Health to test autonomous drug prescribing
    Utah regulators announced a plan to allow an artificial intelligence product to evaluate patients and generate drug prescriptions without prior human review. Nolla Health, a startup, will launch a…
    STAT · 15d agoRegulatoryNeutral↗ source
  • Vaxcyte’s pneumococcal vaccine meets primary goals in Phase 3 trial, challenging Pfizer and Merck
    Vaxcyte announced that its experimental pneumococcal vaccine, VAX-31, achieved the primary endpoints in a pivotal Phase 3 study. The data, presented in a company release, show the shot met its pred…
    STAT · 15d agoPositive readoutPositive↗ source
  • Vaxcyte's experimental pneumococcal vaccine meets primary endpoints in Phase 3 trial
    Vaxcyte announced that its experimental pneumococcal vaccine, VAX-31, achieved the primary endpoints in a Phase 3 trial. The study enrolled just over 3,500 adults aged 50 and older who were random…
    STAT · 15d agoPositive readoutPositive↗ source
  • 2026 Nobel Prize in Medicine awarded for optogenetics, the light-controlled brain research tool
    Karl Deisseroth, Peter Hegemann and Georg Nagel were named the 2026 Nobel laureates in Physiology or Medicine for their work on light-gated ion channels and the optogenetics technique. The Karolins…
    STAT · 15d agoPositive↗ source