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3,028 stories matching this filter · ← front page

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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
  • Key Biopharma Conferences to Watch in 2027 Highlight Industry Trends
    The article lists major medical meetings slated for 2027 that serve as platforms for companies to present clinical data and network. Highlights include the J.P. Morgan Healthcare Conference in ear…
    BioPharma Dive · 14d agoNeutral↗ source
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  • 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 · 15d 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 · 15d 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 · 14d agoNeutral↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 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 · 15d 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
  • Vaxcyte's next-gen pneumococcal vaccine matches leading shots in Phase 3 trial
    Vaxcyte reported that its experimental pneumococcal vaccine, VAX-31, achieved its primary efficacy goals in the first of three Phase 3 studies. In adults aged 50 and older, the vaccine performed o…
    BioPharma Dive · 15d 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 · 16d agoPositive readoutPositive↗ source
  • Nobel Prize honors optogenetics pioneers; Roche licenses Alector’s Parkinson’s enzyme therapy
    The Nobel Committee awarded this year’s Physiology or Medicine prize to three scientists whose work created the field of optogenetics. Their discoveries of a light‑sensing protein in algae and its…
    BioPharma Dive · 15d agoDealPositive↗ 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 · 16d agoApprovalPositive↗ source
  • Shionogi to acquire Texas-based IntraBio for $2 billion, adding marketed rare-disease drug Aqneursa
    Shionogi announced Monday it will buy IntraBio, a Texas biotech, for $2 billion in cash, making IntraBio a wholly owned subsidiary of its U.S. division. The deal gives Shionogi ownership of Aqneur…
    BioPharma Dive · 15d agoDealPositive↗ source
  • AI drives faster drug development and reshapes biopharma manufacturing facilities
    AI is speeding up the identification of drug candidates, turning years of laboratory work into months by analyzing large biological datasets and accelerating early‑stage development. This accelera…
    BioPharma Dive · 16d agoPositive↗ 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 · 16d 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 · 16d 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 · 16d agoPositive readoutPositive↗ 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