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1,822 stories matching this filter · ← front page

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  • With new data, Regenxbio to seek FDA approval of Duchenne gene therapy
    Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”
    BioPharma Dive · 3mo ago↗ source
  • STAT+: Three years of declining overdose deaths begets cautious optimism and some concerns
    The next FDA leader, how the CDC is responding to hantavirus, and more health news from Morning Rounds
    STAT · 3mo ago↗ source
  • STAT+: Biogen’s tau-targeting Alzheimer’s drug posts mixed results in mid-stage study
    Biogen is moving its tau-targeting Alzheimer's drug into Phase 3 studies, despite mixed data from a Phase 2 trial.
    STAT · 3mo ago↗ source
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Infectious Disease345
  • STAT+: CREATE Medicines, a biotech company developing CAR-T therapies, raises $122 million
    CREATE Medicines has a new name, an expanded pipeline, and now fresh funding to propel the company’s first CAR-T candidates through human trials.
    STAT · 3mo ago↗ source
  • STAT+: Regenxbio says Duchenne gene therapy succeeded in clinical trial, paving way for FDA submission
    Regenxbio said its experimental gene therapy for Duchenne muscular dystrophy succeeded in a trial, paving the way for a submission to the FDA.
    STAT · 3mo ago↗ source
  • STAT+: ‘No drama’ Diamantas should serve biotech well as acting FDA chief
    Kyle Diamantas, the acting commissioner of the FDA, is expected to be a drama-free, stabilizing caretaker at the top of the agency.
    STAT · 3mo ago↗ source
  • STAT+: Treatment for alcohol addiction is undergoing a seismic shift. Many say it’s overdue
    The surging popularity of alternatives to Alcoholics Anonymous represents a seismic shift in the alcohol treatment landscape. Many say it's overdue.
    STAT · 3mo ago↗ source
  • Opinion: Using AI in addiction medicine could be particularly risky
    "AI can make great strides in medical decision support, but unfiltered interaction between agent and patient is dangerous," writes Steve D. Klein.
    STAT · 3mo ago↗ source
  • Hantavirus risk remains low, CDC says, citing its ‘playbook’ response
    Despite rising concern about the hantavirus outbreak on a cruise ship, two CDC doctors say the risk to the public remains low.
    STAT · 3mo ago↗ source
  • Officials say $1.3 billion in Medicaid money to California will be deferred over suspicions of fraud
    Vice President JD Vance announced a $1.3 billion deferral in Medicaid reimbursements to California, as part of an initiative to root out fraud in federal health programs.
    STAT · 3mo ago↗ source
  • Opinion: The hantavirus is a wake-up call. Will the Trump administration answer it?
    Arriving in the isolation ward of a biocontainment hospital is an unsettling, scary experience. In 2014, I spent 19 days in one while being treated for Ebola, watching the news…
    STAT · 3mo ago↗ source
  • Opinion: Hospitals are silencing doctors online, and it’s fueling the health misinformation crisis
    Hospitals and health systems need to loosen the reins and let physicians combat social media misinformation, writes Adam Goodcoff.
    STAT · 3mo ago↗ source
  • STAT+: What the Trump administration wants in its next FDA leader
    Leaders want the next FDA commissioner to be someone who can rebuild trust, focus on food policy, and drive drug-approval reforms.
    STAT · 3mo ago↗ source
  • U.S. overdose deaths fell again in 2025, but some worry about policy and drug supply changes
    About 70,000 Americans died of drug overdoses last year — about 14% fewer than the previous year, according to preliminary government data.
    STAT · 3mo ago↗ source
  • FDA’s leadership void leaves biotech with renewed ‘uncertainty’
    Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted policies with an unclear future.
    BioPharma Dive · 3mo ago↗ source
  • Lilly data point to ‘maintenance’ strategies for GLP-1 weight loss
    A pair of trial results published in medical journals suggest switching from high-dose injectables to lower doses or pills could help people with obesity keep their weight down over the long term.
    BioPharma Dive · 3mo ago↗ source
  • Medicare halts enrollment of new hospice, home health providers
    The Centers for Medicare and Medicaid Services said it will pause the enrollment of new hospice and home health providers.
    STAT · 3mo ago↗ source
  • The ‘velocity of obesity’ aims to show which nations are slowing an epidemic
    A study finds the rise in U.S. obesity rates have hit a plateau in children but are still climbing for adults, and are still high compared to those in other…
    STAT · 3mo ago↗ source
  • Assertio accepts new buyout bid; AI biotech Isomorphic banks $2B
    Assertio’s latest offer represents a roughly 31% premium over an initial acquisition proposal. Elsewhere, Kyverna is readying a first-of-its-kind approval application and AC Immune is swapping CEOs.
    BioPharma Dive · 3mo ago↗ source
  • New subpoena suggests DOJ has begun criminal investigation of gender-affirming care
    Several hospitals have received federal grand jury subpoenas regarding gender-affirming care for minors, suggesting a criminal investigation has begun.
    STAT · 3mo ago↗ source
  • STAT+: Gene therapy viruses linked to a boy’s tumor
    The case for Makary as the WOAT, Cassidy's seat at risk ahead of midterms, and other biotech news from The Readout
    STAT · 3mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about FDA’s Makary resigning, a Lilly weight loss drug trial, and more
    FDA Commissioner Marty Makary is resigning, and Kyle Diamantas, the agency's top food regulator, will step in as acting commissioner
    STAT · 3mo ago↗ source
  • STAT+: AI medical devices’ dirty FDA secret
    In this edition of STAT's AI Prognosis newsletter: A look at the quirks of the most common FDA medical device approval pathway, sepsis algorithms, and more.
    STAT · 3mo ago↗ source
  • Extreme heat is worsening faster for Black Americans
    Bill Cassidy's can't-win conundrum, what RFK Jr. gets right and wrong about antidepressants, and more health news
    STAT · 3mo ago↗ source
  • [Podcast] Closing the Distance in Cancer Care
    This podcast episode explores the critical role community oncology plays in the U.S. healthcare system and why supporting its growth and autonomy matters for patients and providers.
    BioPharma Dive · 3mo ago↗ source