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1,997 stories matching this filter · ← front page

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  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 1d agoCRLNegative↗ source
  • Trump’s vaccine executive order likely erodes public trust, says epidemiologist
    President Trump signed an executive order that claims to restore confidence in childhood vaccines by scaling back state mandates and trimming the recommended schedule from 18 diseases to 11. The o…
    STAT · 1d agoRegulatoryNegative↗ source
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  • Trump pushes controversial changes to MMR vaccine policy, eclipsing new food additive rule
    President Trump has shifted the national conversation back to vaccine policy, calling for the measles‑mumps‑rubella (MMR) vaccine to be broken up into separate shots. The proposal has sparked immed…
    STAT · 1d agoRegulatoryNegative↗ source
  • FDA rejects ITM Isotope's radiopharmaceutical therapy over manufacturing problems, halting potential competitor to Novartis
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich SE, citing manufacturing deficiencies. The therapy was desig…
    STAT · 1d agoRegulatoryNegative↗ source
  • Skylark Bio launches first-in-human gene therapy trial targeting deafness
    Skylark Bio, which has operated in stealth, announced that it has dosed the first patient in a gene-therapy trial aimed at treating hearing loss. The study marks the company's entry into the emergi…
    STAT · 1d agoPositive↗ source
  • Austria launches up to €100 million anchor investment for growth fund, aiming to channel half‑billion euros into biotech
    Austria's government announced a new national Startup & Scaleup Fund as part of the 2027/2028 budget, with an anchor investment of up to €100 million. The public money is designed to attract priva…
    BioSpace · 1d agoPositive↗ source
  • French study finds stopping statins in low-risk adults over 75 does not raise mortality
    A new French non-inferiority study published in Lancet Healthy Longevity examined whether discontinuing statin therapy in people older than 75 who have no prior cardiovascular disease would affect…
    STAT · 1d agoPositive readoutNeutral↗ source
  • Health insurers' AI spending meets reality check as UnitedHealth pledges $1.5 billion and CVS outlines its own budget
    Two of the largest publicly traded health insurers are emphasizing their artificial‑intelligence initiatives, but industry observers say the hype may outpace actual results. UnitedHealth Group dis…
    Endpoints · 1d agoNeutral↗ source
  • Nurses voice concerns on AI while regulators outline RAPID pathway for breakthrough devices
    The latest STAT Health Tech newsletter, dated August 11, 2026, highlights two contrasting developments in health technology. Nurses interviewed for the piece express skepticism about the impact of…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Silence causes uproar in rare blood cancer space as data sets high bar for competitors
    The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Taked…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Nonprofit North Star Review Board offers independent model to fix IRB oversight issues
    Founders Stephen Rosenfeld and Patricia Seymour created the not‑for‑profit North Star Review Board after becoming disillusioned with the current system of institutional review boards (IRBs) that ov…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Nurses push for involvement as AI threatens jobs and patient care
    Nurses, the largest segment of the health‑care workforce, are increasingly vocal about the risks that clinical artificial intelligence poses to their employment and to patient safety. At Montefior…
    STAT · 1d agoNegative↗ source
  • MoonLake Immunotherapeutics’ vague data on its autoimmune candidate draws criticism
    Adam Feuerstein notes that MoonLake Immunotherapeutics announced "positive" results for its autoimmune drug candidate but released data that is difficult to interpret. He reminds readers that biot…
    STAT · 1d agoNegative↗ source
  • FDA rejects ITM radiopharma therapy while WHO defends immunization schedules
    The U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…
    raps · 1d agoRegulatoryNeutral↗ source
  • PIC/S releases revised guide on qualification and validation studies for pharma manufacturing
    PIC/S has issued an updated guideline that outlines general principles for qualification and validation studies in pharmaceutical manufacturing facilities. The new guide is intended for both inspe…
    raps · 1d agoRegulatoryNeutral↗ source
  • AbbVie, Novartis and Bristol Myers Squibb sue Illinois over 340B drug discount law
    AbbVie, Novartis and Bristol Myers Squibb each filed separate lawsuits in Illinois this week. The suits challenge a state law that seeks to regulate how manufacturers participate in the 340B drug…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Abortion care shifts to remote and private channels as patients seek help outside clinics
    Patients are increasingly turning to non‑clinical avenues for abortion information, a trend that began before the Dobbs decision. A family physician recounts a recent encrypted message from a teena…
    STAT · 1d agoNeutral↗ source
  • Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs
    A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.…
    raps · 1d agoRegulatoryNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • Tenax Therapeutics' heart failure drug TNX-103 misses primary endpoint in Phase 3, shares plunge 85%
    Tenax Therapeutics announced that its investigational heart failure drug TNX-103 failed to meet the primary efficacy endpoint in the Phase 3 LEVEL trial. The trial, which enrolled patients with pu…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • Eli Lilly's $3.8 B acquisition of AtaiBeckley signals growing confidence in psychedelics for depression
    Psychedelics are being touted as a potential solution for patients who still struggle to find lasting relief from existing FDA‑approved psychiatric medicines. The article notes that many individual…
    BioSpace · 2d agoDealPositive↗ source
  • AbCellera reports striking Phase 2 results for hot-flash treatment, shares jump 31%
    AbCellera Biologics announced positive Phase 2 data for its neurokinin-3 receptor antagonist aimed at relieving vasomotor symptoms such as hot flashes. The company described the results as strikin…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Jazz Pharma to acquire Actio Biosciences for up to $1.3 billion, adding experimental KCNT1 epilepsy drug
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, paying $820 million in cash with up to $500 million in milestone payments. The deal is expected to close by the end of the year.…
    BioSpace · 2d agoDealPositive↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences for $820 million upfront, targeting ultra-rare epilepsy
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, a company developing an ultra‑rare epilepsy therapy. The transaction includes an upfront cash payment of $820 million, with the p…
    Endpoints · 2d agoDealPositive↗ source