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2,962 stories matching this filter · ← front page

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  • Dana-Farber and Beth Israel Lahey Health break ground on $1.68 billion cancer hospital in Boston
    Officials from Dana-Farber Cancer Institute and Beth Israel Lahey Health announced the start of construction on a new dedicated cancer hospital in Boston's Longwood area. The project is budgeted at…
    STAT · 20d agoDealPositive↗ source
  • Rapport Therapeutics' Phase 2 Bipolar Mania Trial Meets Primary Endpoint, Though Effect Size Below Target
    Rapport Therapeutics reported that its phase 2 study of RAP-219 in bipolar mania met the primary endpoint, showing a statistically significant improvement on the Young Mania Rating Scale (YMRS) at…
    Fierce Biotech · 21d agoPositive readoutNeutral↗ source
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  • Midterm ballot measures spotlight abortion, transgender rights and Medicaid expansion
    Voters in the upcoming midterm elections will weigh a series of state ballot questions that address contentious health topics such as abortion access, transgender health care and the expansion of M…
    STAT · 21d agoRegulatoryNeutral↗ source
  • Bristol Myers Squibb leads $237 million Series E for Pathos AI and launches Alzheimer's collaboration
    Bristol Myers Squibb (BMS) headed a financing round that raised $237 million for biotech Pathos AI. The Series E funding will support Pathos AI's development of its AI‑driven platform for drug dis…
    Fierce Biotech · 21d agoDealPositive↗ source
  • EY report says MedTech growth driven by commercial leaders, AI and expanding into new care settings
    The latest EY Pulse of the MedTech Industry report looks at the period from 2025 through the first half of 2026. It finds that innovation has spurred more dealmaking and R&D spending, while artific…
    Fierce Biotech · 21d agoPositive↗ source
  • Pfizer halts phase 2 trial of CXCR5 antibody for immune thrombocytopenia
    Pfizer announced it is ending a phase 2 study of its CXCR5-targeting antibody PF-06835375 in patients with primary immune thrombocytopenia (ITP). The decision was described as a business decision a…
    Fierce Biotech · 21d agoCRLNegative↗ source
  • FDA issues import alert on Olympus endoscopic devices over quality violations
    The U.S. Food and Drug Administration has issued an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. The alert applies to…
    fda medwatch · 21d agoRegulatoryNegative↗ source
  • Cardinal Health issues updated instructions for Presource kits containing recalled BD Alaris infusion sets
    The FDA CDRH issued an Early Alert to inform the public of a potentially high‑risk device issue involving Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets linked to a re…
    fda medwatch · 21d agoRegulatoryNegative↗ source
  • Nova Biomedical pulls Gen 2.0 StatStrip hospital glucose meters over patient ID software flaw
    Nova Biomedical has issued a recall of its StatStrip Glucose Hospital Meter System Gen 2.0 model after discovering a software issue that could assign glucose results to the wrong patient. The FDA…
    fda medwatch · 21d agoCRLNegative↗ source
  • AstraZeneca partners with Oracle to boost clinical trial patient recruitment using AI
    AstraZeneca announced a collaboration with data-technology firm Oracle to apply artificial-intelligence tools to clinical-trial recruitment. The non-binding agreement will let the partners explore…
    Fierce Biotech · 21d agoDealPositive↗ source
  • FDA issues final guidance on developing and labeling prescription drug apps
    The FDA released its final guidance on Tuesday, outlining how drug sponsors should create, distribute, and label software applications that are used together with prescription medicines. The guida…
    raps · 21d agoRegulatoryPositive↗ source
  • Lawmakers push FDA to close loophole allowing import of counterfeit Eli Lilly obesity drug
    A bipartisan group of U.S. lawmakers is urging the Food and Drug Administration to address a regulatory gap that permits the importation of unapproved versions of retatrutide, an experimental obesi…
    STAT · 20d agoRegulatoryNeutral↗ source
  • Lycia Therapeutics targets $228M IPO to fund food allergy protein degrader programs
    Lycia Therapeutics announced plans for an initial public offering expected to raise about $228 million. The proceeds are intended to support its pipeline of protein degrader therapeutics targeting…
    Fierce Biotech · 21d agoDealNeutral↗ source
  • Proposed ACGME rule changes could strip resident doctors of mandatory rest periods
    Arifeen Rahman, a clinical instructor in rhinology at the Medical University of South Carolina, recounts working 90-hour weeks as a junior otolaryngology resident in 2023, often exceeding the ACGME…
    STAT · 21d agoRegulatoryNegative↗ source
  • FDA and UK regulators discuss new frameworks for generative AI oversight
    At the MedTech Conference in Boston, officials from the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare products Regulatory Agency met to talk about how to regulate generati…
    raps · 21d agoRegulatoryNeutral↗ source
  • New poll gauges U.S. voter attitudes toward transgender sports participation and abortion access
    A recent assessment released by STAT examines how American voters feel about transgender youth competing in school sports and about access to abortion services. The analysis is presented as a concr…
    STAT · 20d agoNeutral↗ source
  • SCRS unveils Eagle Insights Dashboard to benchmark clinical trial site performance
    The Society for Clinical Research Sites introduced a new data intelligence platform called the Eagle Insights Dashboard. The tool provides sponsors and contract research organizations with a compos…
    Fierce Biotech · 20d agoPositive↗ source
  • Nursing home cuts resident care while diverting revenue to real estate, state oversight lacking
    A Boston Globe Spotlight investigation found that a nursing home in Taunton, once praised for high quality, has seen a sharp decline in resident care after a new owner took over. The new owner, El…
    STAT · 20d agoNegative↗ source
  • JAMA paper on OpenEvidence highlights clinician use but raises unanswered questions
    A new study published in JAMA examines how clinicians are employing the OpenEvidence platform, an artificial-intelligence-driven tool designed to assist medical decision-making. The authors highli…
    STAT · 20d agoNeutral↗ source
  • Reporter urges audiences to skip new Elizabeth Holmes documentary
    Matthew Herper, a reporter covering medical innovation, recounts his two interviews with Elizabeth Holmes in 2015, at the peak of Theranos hype. The first interview occurred just before John Carre…
    STAT · 20d agoNegative↗ source
  • Update: Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers
    The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus)…
    fda medwatch · 21d ago↗ source
  • Early Alert: Cardinal Health Issues Correction for Presource Packs Containing BD Alaris Pump Infusion Sets
    Cardinal Health Presource Kits containing recalled BD Alaris Pump Infusion Sets should be corrected prior to continued use.
    fda medwatch · 21d ago↗ source
  • Disc spins past FDA rejection with ‘overwhelmingly positive’ phase 3 data for rare disease drug
    A phase 3 trial of Disc Medicine’s bitopertin has hit both co-primary endpoints and all secondary endpoints, positioning the biotech to refile for approval of the once-rejected rare disease drug ca…
    Fierce Biotech · 22d agoApprovalPositive↗ source
  • Roche signs $15 billion ADC partnership with China's Hansoh Pharma
    Roche has re-entered a partnership with China's Hansoh Pharmaceutical, signing a $15 billion biobucks agreement. The deal covers a broad portfolio of antibody-drug conjugate programs, including tw…
    Fierce Biotech · 22d agoDealPositive↗ source
  • Israeli biotech's inhaled exosome therapy cuts respiratory failure and mortality in ARDS phase 2b trial
    Nano24, an Israeli biotech company, tested its inhaled exosome product EXO‑CD24 in a mid‑stage study involving 90 patients with acute respiratory distress syndrome. The trial compared the therapy,…
    Fierce Biotech · 22d agoPositive readoutPositive↗ source