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  • 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
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  • 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
  • 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
  • BioSpace podcast highlights Q3 job market gains and sharp layoff decline for biopharma talent
    BioSpace Vice President of Marketing Chantal Dresner and content manager Angela Gabriel released a bonus podcast episode reviewing the biopharma job market in the third quarter of 2026. They repor…
    BioSpace · 21d agoPositive↗ 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
  • BioSpace releases Q3 2026 biopharma job market report showing upbeat hiring trends
    BioSpace has published its third quarter 2026 biopharma job market report, which examines hiring activity, workforce cuts and overall employment patterns across the sector. The analysis highlights…
    BioSpace · 21d agoPositive↗ 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 · 21d agoNeutral↗ 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 · 21d 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 · 21d 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
  • Roche signs $15 billion ADC partnership with China's Hansoh, offering $400 million upfront
    Roche announced a licensing agreement with Hansoh Pharmaceutical to develop a broad portfolio of antibody-drug conjugates (ADCs).\n\nThe deal includes an upfront cash payment of $400 million and a…
    BioSpace · 22d agoDealPositive↗ source
  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 21d agoApprovalPositive↗ source
  • Sanofi breaks ground on Frankfurt insulin API plant with €400 million German aid
    Sanofi has started construction of a new insulin active pharmaceutical ingredient (API) manufacturing facility at its Frankfurt site in Germany. The plant, covering about 36,000 square meters, is…
    BioSpace · 21d agoDealPositive↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.1 billion, gaining Phase 3 PV siRNA asset
    Merck KGaA announced it will buy Silence Therapeutics for about $1.1 billion, giving the German group a foothold in hematology. Silence, a UK-based RNA specialist, develops short interfering RNA m…
    BioSpace · 22d agoDealPositive↗ source
  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic protoporphyria, setting stage for FDA resubmission
    Disc Medicine's bitopertin, being developed for erythropoietic protoporphyria (EPP), a rare blood disorder that causes painful light sensitivity, had its accelerated FDA application rejected in Feb…
    BioSpace · 22d agoPositive readoutPositive↗ source
  • Gilead’s oral ulcerative colitis drug shows significant remission in Phase 2 trial
    Gilead Sciences reported results from a Phase 2 trial of its oral ulcerative colitis drug emvistegrast. In the study, patients took a 200 mg daily dose for 12 weeks and achieved a 23% placebo-adju…
    STAT · 22d agoPositive readoutPositive↗ source
  • Merck acquires Silence Therapeutics for $1.3B; Hansoh Pharma signs $15B deal with Roche
    German Merck announced the acquisition of Silence Therapeutics in a transaction valued at $1.3 billion. In China, Hansoh Pharma disclosed a partnership with Roche that involves a $15 billion drug…
    raps · 22d agoDealNeutral↗ source
  • Trump signs executive order to create NIH division and White House task force for women’s health
    President Donald Trump signed an executive order on Monday establishing a new division within the National Institutes of Health and a White House task force focused on women’s health. The order dir…
    STAT · 21d agoRegulatoryNeutral↗ source
  • EyePoint cuts half its staff and ends wet AMD trials after second Phase 3 failure, pivots to diabetic macular edema
    EyePoint said it is launching a strategic review after its investigational drug duravyu failed another Phase 3 study in wet age‑related macular degeneration. The company reported that the top‑line…
    BioSpace · 21d agoLayoffsNegative↗ source
  • China proposes new limits on foreign biotech acquisitions to protect domestic drug development
    China is drafting new rules that would restrict foreign companies from acquiring Chinese biotech assets deemed critical to the nation's drug development sector. The proposal aims to keep control o…
    STAT · 22d agoRegulatoryNeutral↗ source