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5,008 stories matching this filter · ← front page

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  • KymaThera secures $80M Series B to advance oral PI3Kα inhibitor K-1728 as biotech peers raise funds and go public
    KymaThera, a San Diego biotech, announced an $80 million Series B round to fund development of its pan-mutant selective PI3Kα inhibitor, K-1728. The oral candidate is planned to enter Phase 1 clin…
    Endpoints · 1mo agoDealPositive↗ source
  • Doctor warns AI-driven documentation may boost hospital bills without improving care
    A resident physician writes that recent Blue Cross Blue Shield research has sparked anger by suggesting hospitals use AI tools to increase charges without adding care. The study claims hospitals e…
    STAT · 1mo agoNegative↗ source
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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 · 1mo 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 · 1mo agoNeutral↗ source
  • 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 · 1mo agoRegulatoryNeutral↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoNeutral↗ 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 · 1mo agoNeutral↗ source
  • Secretive new issue links diverse groups, raises concerns for pharma industry
    The article, dated October 6, 2026, was written by senior reporter Max Bayer and carries the title “In DC, a secretive new thorn has appeared in pharma’s side.” It notes that the Seattle Latino Ch…
    Endpoints · 1mo agoNegative↗ 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 · 1mo agoNeutral↗ source
  • Shionogi makes $2B rare disease play with IntraBio buy
    With its acquisition of IntraBio, Shionogi will gain ownership over Aqneursa, which could hit peak global sales of $1 billion across its two indications in Niemann-Pick disease type C and ataxia-te…
    BioSpace · 1mo ago↗ source
  • FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues
    Despite the regulatory delay, Novo is still expecting a 2027 launch for its hemophilia A drug denecimig.
    BioSpace · 1mo ago↗ source
  • Vaxcyte's experimental pneumococcal vaccine VAX-31 meets Phase 3 endpoints, shares jump 35%
    Vaxcyte announced that its experimental pneumococcal vaccine VAX-31 achieved its primary objectives in a Phase 3 trial involving adult participants. The trial results showed that the vaccine met t…
    Endpoints · 1mo agoPositive readoutPositive↗ 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 · 1mo agoApprovalPositive↗ source
  • Vaxcyte’s VAX-31 shows superior results in Phase 3, beating Pfizer and Merck’s pneumococcal vaccines and sparking $8 bn market hopes
    Vaxcyte reported that its investigational pneumococcal conjugate vaccine, VAX-31, met the co-primary endpoints in a Phase 3 trial, demonstrating non-inferiority to the existing shots from Pfizer an…
    BioSpace · 1mo agoPositive readoutPositive↗ 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 · 1mo agoPositive readoutPositive↗ source
  • Genentech signs up to develop Alector’s preclinical blood-brain barrier therapy in $1.27 billion deal
    Genentech, a Roche subsidiary, announced a deal with Alector to obtain exclusive rights to its preclinical blood-brain barrier delivery asset, AL050. The agreement provides $100 million upfront an…
    BioSpace · 1mo agoDealPositive↗ source
  • FDA urged to boost US access to new and experimental drugs as trials shift to China
    The piece highlights that the FDA has taken steps such as launching Operation TrialBlazer and tightening review of foreign clinical data, but argues that further action is required to keep the Unit…
    BioSpace · 1mo agoRegulatoryNegative↗ 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 · 1mo agoApprovalPositive↗ source
  • Lilly adds $870M to Gate Bioscience partnership to pursue new drug targets
    Eli Lilly is expanding its collaboration with Gate Bioscience, adding a new financial commitment of more than $870 million. The original July 2025 agreement gave Lilly access to Gate’s "Molecular…
    BioSpace · 1mo agoDealPositive↗ source
  • Shionogi agrees $2 billion upfront purchase of IntraBio, adding oral rare-disease drug Aqneursa to its portfolio
    Shionogi announced it will acquire Austin-based biotech IntraBio for $2 billion paid upfront. The deal brings IntraBio’s oral therapy Aqneursa into Shionogi’s rare‑disease pipeline, expanding its…
    Endpoints · 1mo agoDealPositive↗ 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 · 1mo agoPositive readoutPositive↗ source